Reported Feb 14, 2018 · Terminated
BrightView X, Model #882478 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 X, Model #882478
- 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 X, Model # 882478
- Serial Numbers
118 of 118 codes
11000044110000061100003311000025110001051100001611000072110001161100000311000018110000661100004711000101110000651100011411000078110000511100004611000026110000071100001011000027110000321134000111000055110000701100008411000088110000681100005211000057110000501100006711000102110000611100009511000023110000941100006011000054113400041100008311000091110000984000570110000631100006211000013110000151100003511000081110000091100001711000110110000901100010711340003110000561100002911000100
- 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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