Reported Dec 27, 2023 · Completed
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into…
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
- Lot codes and dates
- System Code728143 and 728144
- UDI
330 of 330 codes
(01)00884838105508(21)34035(01)00884838105508(21)34029(01)00884838105508(21)34030(01)00884838105508(21)550007(01)00884838105508(21)550009(01)00884838105508(21)550068(01)00884838105508(21)550012(01)00884838105508(21)550044(01)00884838105508(21)550049(01)00884838105508(21)34021(01)00884838105508(21)34076(01)00884838105508(21)34094(01)00884838105508(21)500519(01)00884838105508(21)550024(01)00884838105508(21)550048(01)00884838105508(21)550062(01)00884838105508(21)550003(01)00884838105508(21)34063(01)00884838105508(21)550027(01)00884838105508(21)550029(01)00884838105508(21)552006(01)00884838105508(21)552007(01)00884838105508(21)552009(01)00884838105508(21)500502(01)00884838105508(21)550020(01)00884838085015(21)500367(01)00884838085015(21)500379(01)00884838085015(21)500521(01)00884838085015(21)500138(01)00884838085015(21)500308(01)00884838105508(21)34074(01)00884838105508(21)34102(01)00884838105508(21)34053(01)00884838105508(21)34092(01)00884838105508(21)34008(01)00884838105508(21)550026(01)00884838105508(21)34028(01)00884838105508(21)34039(01)00884838105508(21)34048(01)00884838105508(21)34069(01)00884838085015(21)500110(01)00884838085015(21)500111(01)00884838105508(21)34041(01)00884838105508(21)34036(01)00884838105508(21)34065(01)00884838105508(21)34061(01)00884838085015(21)500433(01)00884838105508(21)500517(01)00884838105508(21)550060(01)00884838105508(21)550061(01)00884838085015(21)33023(01)00884838105508(21)34001(01)00884838085015(21)500443(01)00884838105508(21)500452(01)00884838105508(21)550035(01)00884838105508(21)34004(01)00884838105508(21)34005(01)00884838105508(21)500503(01)00884838105508(21)550042(01)00884838105508(21)510043
- Equipment Number
660 of 660 codes
971273449712735197127346948087799487827694808780949841909616187596457814975985289934902510035372294660960965063839648395196454302950857349662129195887893959845339726508597320687974651379390967495205133835413558354196091681806837064698831547899159836100665288986849581002215079616076296000308962360849662118096621365966197928371982683720363983815739816794197545869985615299279743593514492975655709758208093333252955103879333325493575188965793999655629096556291936827389628121394354758
- Amount recalled
- 330 units
Where it was sold
Why it was recalled
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
This product could cause temporary or reversible health problems — stop using it.
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