Reported Aug 17, 2016 · Terminated
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
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?
- Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
- Lot codes and dates
- Brilliance iCT SP Model No. 728311
- S/N
200107200003200011200009200017200074200022200013200027200049200032200030200043200040200038200047200051200044200063200061200068200067200089200088200092200093200101200097200100200105200109200121200204200111200117200127200131200200200205200138200202200201200203200209200210200206200208200207200211200019200015200029200024200023200025200026200041200086200102200213
- Amount recalled
- 57 Units
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.
This product could cause temporary or reversible health problems — stop using it.
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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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