Reported Mar 9, 2016 · Terminated
BrightView are gamma cameras; 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 are gamma cameras; Designed for single or dual detector nuclear imaging.
- Lot codes and dates
677 of 677 codes
Model # 882480Serial #'s: 40000024000002.75400000340000044000006400000740000084000009400001040000114000013400003040000314000032400003340000344000035400003640000374000038400003940000404000041400004340000444000045400004640000474000048400004940000504000051400005240000534000054400005540000564000057400005840000594000060400006140000624000064400006540000664000068400007040000714000072400007340000744000075400007640000774000078400007940000804000081
- Amount recalled
- 677 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
Why it was recalled
The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause
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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