FDA (Devices) recall action 72599

Philips Electronics North America Corporation recalled 29 products on 2016-02-10

The FDA (Devices) publishes a recall like this one as 29 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 29 pages.

Products: 29
Announced: 2016-02-10
Critical: 0
Units: 385,613

Why these products were recalled

The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 29

HighFDA (Devices)··2016-02-10
Philips INTEGRIS Allura 9 Biplane Recalled for Image Interpretation Risk
Philips is recalling INTEGRIS Allura 9 Biplane systems because still images may be misinterpreted as live images, posing a risk to patient safety.
Product
INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and i
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1 state
HighFDA (Devices)··2016-02-10
Philips Recalls Allura Xper FD20 Biplane Systems Due to Image Display Error
Philips is recalling Allura Xper FD20 Biplane systems because a software issue may cause still images to be misinterpreted as live images.
Product
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent pl
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Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.
Product
INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and intervent
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Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.
Product
INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.
Product
INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventio
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1 state
HighFDA (Devices)··2016-02-10
Philips Allura Centron Medical Imaging System Recalled for Image Display Error
Philips is recalling Allura Centron systems because a software error may cause still images to be misinterpreted as live images during medical procedures.
Product
Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maxi
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1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS Allura X-Ray Systems Recalled for Image Display Error
Philips is recalling INTEGRIS Allura X-ray systems because a software error may cause still images to be displayed as live images, potentially leading to misinterpretation.
Product
INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular a
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1 state
HighFDA (Devices)··2016-02-10
Philips Allura Xper FD20/15 Recall for Image Display Error
Philips is recalling 13,297 Allura Xper FD20/15 systems worldwide because a software error may cause still images to be interpreted as live images.
Product
Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisat
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Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips Allura Xper FD20 Recall for Image Interpretation Error
Philips is recalling Allura Xper FD20 systems because still images may be misinterpreted as live images, potentially affecting diagnostic accuracy.
Product
Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements
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Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images during procedures.
Product
INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips Allura Xper OR Table Recalled for Image Interpretation Error
Philips is recalling Allura Xper OR Tables because still images may be mistaken for live images, potentially affecting diagnostic accuracy.
Product
Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements,
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Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS Allura X-ray Systems Recalled for Image Display Error
Philips is recalling INTEGRIS Allura X-ray systems because a software error may cause still images to be displayed as live images, potentially leading to misinterpretation.
Product
INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images during procedures.
Product
INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips UNIQ and Allura Systems Recall for Image Interpretation Error
Philips is recalling UNIQ and Allura systems because a software issue may cause still images to be misinterpreted as live images during medical procedures.
Product
UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral,
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Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips Allura Xper FD20/20 Recall for Image Interpretation Error
Philips is recalling 13,297 Allura Xper FD20/20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.
Product
Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisat
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips Allura Xper X-ray Systems Recalled for Image Interpretation Error
Philips is recalling Allura Xper FD10 systems because a software defect may cause still images to be mistaken for live images during cardiovascular procedures.
Product
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantati
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1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.
Product
INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and i
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images.
Product
INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional pr
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be misinterpreted as live images.
Product
INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be misinterpreted as live images.
Product
INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips Allura Medical Imaging Systems Recalled for Image Interpretation Error
Philips is recalling Allura CV20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.
Product
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 k
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips UNIQ and Allura Systems Recalled for Image Interpretation Error
Philips is recalling UNIQ and Allura imaging systems because still images may be misinterpreted as live images during medical procedures.
Product
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebra
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips Allura Xper Biplane OR Table Recall for Image Interpretation Error
Philips is recalling Allura Xper FD20 Biplane OR Tables because still images may be incorrectly interpreted as live images during use.
Product
Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips Allura Xper OR Table Recall for Image Interpretation Risk
Philips is recalling Allura Xper FD20 OR Tables because live and still images may be misinterpreted, potentially affecting diagnostic accuracy.
Product
Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placemen
Category
Distribution
1 state
HighFDA (Devices)··2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Risk
Philips is recalling INTEGRIS and Allura medical imaging systems because software issues may cause still images to be misinterpreted as live images during procedures.
Product
INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
Category
Distribution
1 state