FDA (Devices) recall action 71177
The FDA (Devices) publishes a recall like this one as 11 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 11 pages.
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
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.
Philips is recalling 153 Ingenuity CT systems in China because the patient couch unexpectedly descended to its lowest point during an exam.
Philips is recalling 153 Brilliance CT 16 Air systems because the patient couch may unexpectedly descend to its lowest point during an exam.
Philips is recalling 153 Brilliance CT 6 Air systems because the patient couch unexpectedly descended during exams. The units were distributed in China.
Philips is recalling 153 Brilliance CT 64 systems because the patient couch may unexpectedly descend during an exam.
Philips Medical Systems is recalling 153 Brilliance CT Big Bore Oncology systems because the patient couch may unexpectedly descend during an exam.
Philips is recalling 153 MX8000 CT scanners because the patient couch may descend unexpectedly during an exam.
Philips Medical Systems is recalling 153 Brilliance CT 40 systems because the patient couch may unexpectedly descend to its lowest point during an exam.
Philips Medical Systems is recalling 153 Brilliance CT 16 Water systems because the patient couch may unexpectedly descend during an exam.
Philips Medical Systems is recalling 153 Brilliance iCT computed tomography systems because the patient couch may unexpectedly descend during an exam.
Philips is recalling 153 Brilliance CT 16 Power systems because the patient couch may unexpectedly descend during an exam.
Philips Medical Systems is recalling 153 Brilliance CT 10 Air systems in China because the patient couch may unexpectedly descend during an exam.