FDA (Devices) recall action 70370

Philips Medical Systems, Inc. recalled 9 products on 2015-12-09

The FDA (Devices) publishes a recall like this one as 9 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 9 pages.

Products: 9
Announced: 2015-12-09
Critical: 0
Units: 88

Why these products were recalled

Monitor Ceiling Suspension system may fall

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.

1–9 of 9

SevereFDA (Devices)··2015-12-09
Philips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling three INTEGRIS vascular systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and
Category
Distribution
0 states
HighFDA (Devices)··2015-12-09
Philips Allura BiPlane Ceiling Suspension System Recall for Fall Risk
Philips Medical Systems is recalling five Allura BiPlane X-ray systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLANE R7.9 722013 Allura Xper FD20 BIPLANE R7.10 Product Usage: The Allur
Category
Distribution
0 states
SevereFDA (Devices)··2015-12-09
Philips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 16 Allura Xper cardio systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and throm
Category
Distribution
0 states
HighFDA (Devices)··2015-12-09
Philips INTEGRIS Cardio System Ceiling Suspension Recall
Philips is recalling eight INTEGRIS cardio systems because the ceiling suspension system may fall.
Product
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and th
Category
Distribution
0 states
SevereFDA (Devices)··2015-12-09
Philips Xper Vascular System Monitor Ceiling Suspension Recall
Philips Medical Systems is recalling 22 Allura Xper vascular systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and
Category
Distribution
0 states
HighFDA (Devices)··2015-12-09
Philips Xper Vascular System Recall for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 10 Xper vascular systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thr
Category
Distribution
0 states
HighFDA (Devices)··2015-12-09
Philips Allura X-Ray System Ceiling Suspension Recall
Philips Medical Systems is recalling INTEGRIS H5000F/Allura 9F X-ray systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and
Category
Distribution
0 states
HighFDA (Devices)··2015-12-09
Philips Allura Xper Series Recall Due to Ceiling Suspension Fall Risk
Philips Medical Systems is recalling nine Allura Xper Series units because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular
Category
Distribution
0 states
SevereFDA (Devices)··2015-12-09
Philips Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 14 Allura Xper Cardio systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and t
Category
Distribution
0 states