Reported Feb 14, 2018 · Terminated
Philips Ingenuity Core 128 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 128 computed tomography x-ray system
- Lot codes and dates
- Ingenuity Core 128 - 728323 SN# -
630 of 630 codes
32000232000132000632000332000532001032000832003032003732001932003332001832002432002932002632003132005932005432005832007432008133620732007932007832006932008032007332011532009232009032008332008432008232009632013332010332010032010133601532013832021320107320111320132320126320114336016320248320123336011320099320122336018320134320215320146320119336013320125320131
- Ingenuity Core 128 - 728323 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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