Reported Feb 14, 2018 · Terminated
Philips Ingenuity CT 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 CT computed tomography x-ray system
- Lot codes and dates
- Ingenuity Core 128 - 728323 SN# -
799 of 799 codes
400140169056906790719074909991129134919492139235925192639268926992729280936795159515952195299538954195489549955495599561957395749579958496009607961496189625963196339638964096469649965396569659966796709678968696889689970397079711972097389740
- 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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