FDA (Devices) recall action 71134
The FDA (Devices) publishes a recall like this one as 35 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 35 pages.
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
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 Medical Systems is recalling 110 iCT SP UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 277 BrightView SPECT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips is recalling 69 GEMINI TF PET/CT 16 Slice systems due to UPS accessory devices that may leak battery acid, overheat, or emit fumes.
Philips Medical Systems is recalling 39 GEMINI TF Big Bore UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 36 Precedence 16 UPS accessory devices used in CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 847 UPS accessory devices for CT scanners due to risks of battery acid leakage, overheating, and fume emission.
Philips is recalling 25 Brilliance CT 6 Slice Air UPS accessories due to risks of battery acid leakage, overheating, and fume emission.
Philips is recalling 11 MX 16 Slice Phase II CT systems because their UPS accessory devices may leak battery acid, overheat, or emit fumes.
Philips is recalling 10 Gemini LXL 16 Slice CT systems worldwide due to UPS accessory defects that may cause battery acid leakage, overheating, or fumes.
Philips Medical Systems is recalling 71 GEMINI TF PET/CT 64 Slice UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling nine Ingenuity PET/MR Uninterruptible Power Supply (UPS) accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 23 Ingenuity Flex UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling Brilliance iCT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips is recalling 15 Gemini GXL 16 Slice CT systems worldwide because their UPS accessory devices may leak battery acid, overheat, or emit fumes.
Philips Medical Systems is recalling 10 FORTE Uninterruptible Power Supply (UPS) accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Philips is recalling 156 Ingenuity CT Uninterruptible Power Supply (UPS) accessory devices due to a risk of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling Extended Brilliance Workstation UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips is recalling 7 Gemini 16 PET/CT Uninterruptible Power Supply units worldwide due to risks of battery acid leakage, overheating, and fumes.
Philips Medical Systems is recalling 337 BrightView XCT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 81 CardioMD III UPS accessory devices for CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 108 BrightView X UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling Precedence 6 UPS accessory devices for CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 11 Forte-JetStream AZ UPS accessory devices used in CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fumes.
Philips Medical Systems is recalling 125 MX 16 Slice UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 215 Ingenuity Core UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.