FDA (Devices) recall action 79666

Philips Medical Systems (Cleveland) Inc recalled 12 products on 2018-04-25

The FDA (Devices) publishes a recall like this one as 12 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 12 pages.

Products: 12
Announced: 2018-04-25
Critical: 0
Units: 1,790

Why these products were recalled

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

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.

1–12 of 12

SevereFDA (Devices)··2018-04-25
Philips Brilliance iCT SP CT Systems Recalled for Emergency Stop Defect
Philips is recalling 19 Brilliance iCT SP CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devi
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0 states
HighFDA (Devices)··2018-04-25
Philips Brilliance 16 Slice CT System Recalled for Emergency Stop Defect
Philips is recalling two Brilliance 16 Slice CT systems because the emergency stop may fail to disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. T
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0 states
SevereFDA (Devices)··2018-04-25
Philips Brilliance Big Bore CT Systems Recalled for Emergency Stop Defect
Philips is recalling 119 Brilliance Big Bore CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.
Product
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and pla
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0 states
HighFDA (Devices)··2018-04-25
Philips IQon Spectral CT Recalled for Emergency Stop Defect
Philips is recalling 47 IQon Spectral CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devi
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0 states
HighFDA (Devices)··2018-04-25
Philips Ingenuity Core 128 CT Systems Recalled for Emergency Stop Defect
Philips is recalling 591 Ingenuity Core 128 CT systems because closing the emergency stop may allow the patient couch to move during loading or unloading.
Product
Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
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0 states
HighFDA (Devices)··2018-04-25
Philips Brilliance 64 CT System Recalled for Emergency Stop Defect
Philips Medical Systems is recalling six Brilliance 64 CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices
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0 states
HighFDA (Devices)··2018-04-25
Philips CT Scanner Recall Due to Emergency Stop Defect
Philips is recalling 106 Brilliance Big Bore CT scanners because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading or unloading.
Product
Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and plan
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0 states
HighFDA (Devices)··2018-04-25
Philips Ingenuity Core CT Systems Recalled for Couch Movement Hazard
Philips is recalling 281 Ingenuity Core CT systems because the emergency stop may fail to lock the couch, allowing it to move during patient loading.
Product
Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices
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0 states
HighFDA (Devices)··2018-04-25
Philips Ingenuity Flex CT Scanner Recall for Emergency Stop Defect
Philips is recalling 151 Ingenuity Flex CT scanners because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These device
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0 states
HighFDA (Devices)··2018-04-25
Philips Ingenuity CT Recall for Emergency Stop Defect
Philips is recalling 172 Ingenuity CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.
Product
Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These
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0 states
HighFDA (Devices)··2018-04-25
Philips Brilliance iCT CT Systems Recalled for Emergency Stop Defect
Philips is recalling 295 Brilliance iCT CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices
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0 states
HighFDA (Devices)··2018-04-25
Philips Brilliance 6 Slice CT System Recalled for Emergency Stop Defect
Philips is recalling Brilliance 6 Slice CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Th
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0 states