Reported Sep 14, 2016 · Terminated
BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
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?
- BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
- Lot codes and dates
117 of 117 codes
110000031100000811000030110000041100000511000006110000071100000911000010110000111100001211000013110000141100001611000017110000181100001911000020110000221100002311000024110000251100002611000027110000281100002911000031110000321100003311000034110000351100003611000037110000381100003911000040110000411100004211000043110000441100004511000046110000471100004811000049110000501100005111000052110000541100005511000056110000571100005811000059110000601100006111000062110000631100006411000065
- Amount recalled
- 117 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
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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