Reported Mar 5, 2014 · Terminated
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT)…
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?
- Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.
- Lot codes and dates
- BrightView SPECT
- Product code
633 of 633 codes
882480Serial #'s: 4000544000002400000340000044000006400000740000084000009400001040000114000013400002940000304000031400003240000334000034400003540000364000037400003840000394000040400004140000434000044400004540000464000047400004840000494000050400005140000524000053400005440000554000056400005740000584000059400006040000614000062400006440000654000066400006740000684000070400007140000724000073400007440000754000076400007740000784000079
- Product code
108 of 108 codes
882478Serial #'s: 1100000311000004110000051100000611000008110000091100001111000012110000131100001411000015110000161100001711000018110000191100002011000022110000231100002411000025110000261100002811000029110000301100003111000033110000341100003611000037110000381100003911000040110000411100004211000043110000451100004611000047110000481100004911000050110000511100005211000054110000551100005611000057110000581100005911000060110000611100006211000063110000641100006511000066110000671100006811000069
- Product code
402 of 402 codes
882482Serial #'s: 60000026000003600000460000056000006600001060000116000012600001360000156000016600001760000186000019600002060000226000023600002460000256000026600002760000286000029600003060000316000032600003360000366000037600003860000406000041600004260000436000044600004560000476000048600004960000506000051600005260000536000054600005560000566000058600005960000606000061600006260000636000064600006560000666000067600006960000706000071
- Amount recalled
- 1,143 units
Where it was sold
Why it was recalled
Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation. When the acquisition was started and the detectors began to move into position, the incorrect calculation resulted in the detectors coming in contact with the patient. As
This product could cause temporary or reversible health problems — stop using it.
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