Reported Jun 3, 2015 · Terminated
Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer…
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 CT 64. Computed Tomography X-ray systems 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
System Code #728231Serial #956897581009710143102671026910275104271043610521105451057910622900979021895203953199532895362953699539195414954279543395471954869554495586956049560595617956289563295640956729575295754 & 95757
- Amount recalled
- 153 units total
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Why it was recalled
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
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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