Reported Feb 14, 2018 · Terminated
BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual…
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 Model 882480 Product UsageBrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only)
- Lot codes and dates
- Brightview Model 882480 Serial Numbers
690 of 690 codes
400041040006514000652400066540006884000350400006540000614000180400022440003214000298400055240002804000378400033640005594000229400026240006814000009400018440005544000516400030340005764000190400030540004114000669400061440003244000612400056640006274000218400012340002874000070400016640002024000102400027640000914000301-140004554000033400036440000084000497400049840006994000012400021340004134000472A4000581400046940006484000510
- Brightview Model 882480 Serial Numbers
- Amount recalled
- 1387 in total
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
- Nationwide
Why it was recalled
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
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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