Reported Feb 14, 2018 · Terminated
Philips Ingenuity Core computed tomography x-ray system
Philips Medical Systems (Cleveland) Inc.
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 Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Philips Ingenuity Core computed tomography x-ray system
- Lot codes and dates
- Ingenuity Core 728321 SN# -
351 of 351 codes
310003310002310001310096310023310017310022310071310105310026310032310042310039310064310059310052333002310055310069310070310088310087310111310090310116310107310009310121310081333009310113310119333015310129520133330053330803330645201531013331013431014331014131015931013531015133304131015731014933303031017033301931016030041520123330145202233303152008310203
- Ingenuity Core 728321 SN# -
- Amount recalled
- N/A
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Why it was recalled
Numerous issues related to software Brilliance iCT 4.1.6 software version.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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