Reported Jul 6, 2016 · Terminated
Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole 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?
- Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Lot codes and dates
Big Bore Radiology System Code 728244Serial numbers 7503375110
- Amount recalled
- 89
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
Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel.
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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