Reported Jan 31, 2018 · Terminated
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
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 - Model 728306 Computed Tomography X-ray systems
- Lot codes and dates
- Brilliance iCT 4.1.6 version
- Brilliance iCT - Model 728306 Codes
495 of 495 codes
100688850251007901004901006678505410040810060485031100703100411100114100314100278100349100654100406100452100453100404100242100115100383100189100347100348100450100748100507100181100469200005100638100195100101100440100223100616100619100134100304100656100436100773100130100621100113850551006001001808506010070410075085041100737100231100615100612100393100643
- Amount recalled
- 559 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
This product could cause temporary or reversible health problems — stop using it.
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