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 is recalling 31 TruFlight Select PET/CT systems because the Uninterruptible Power Supply (UPS) accessory devices may leak battery acid, overheat, or emit fumes.
Philips is recalling Brilliance CT 40 Uninterruptible Power Supply accessories due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling AXIS 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 Medical Systems is recalling 126 UPS accessory devices for CT scanners due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling three GEMINI TF Ready UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fumes.
Philips Medical Systems is recalling 288 Ingenuity Core 128 UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 788 Uninterruptible Power Supply (UPS) accessories for CT scanners due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling 17 Brilliance CT 40 Uninterruptible Power Supply (UPS) accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Philips Medical Systems is recalling two Diamond Select Brilliance CT 16 systems due to a risk of battery acid leakage, overheating, and fumes from the UPS accessory.
Philips Medical Systems is recalling 14 Ingenuity TF UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.