Reported Jan 24, 2018 · Terminated
Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray…
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 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Lot codes and dates
Code 728231SN # 10655
- Amount recalled
- 1
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
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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