Reported Nov 4, 2015 · Terminated
Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional…
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 Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
- Lot codes and dates
- Model No. 728243
- S/N
235 of 235 codes
700770137015702070237028705970617072708370867087710171237124712871587170717371787193720472147221722872317235724672627265727372847328734773537364736573707395740074037434743574627467748174847596761277757794779578037840784178427843784678477848
- S/N
7121717672717595776478447845786278707871787478787879788078827887789478977899790379067912791379157917791979227926793079347952795779587959796479657967797979817986798875106 & 75110
- Amount recalled
- 268 units total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The firm discovered Ring/Dot artifact due to X-ray measurement error.
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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