Reported Sep 14, 2016 · Terminated
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (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?
- BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
- Lot codes and dates
424 of 424 codes
600001660001116000114600012260000026000003600000460000056000006600001060000116000012600001360000156000017600001860000196000020600002260000236000024600002560000266000027600002860000296000030600003160000326000033600003560000366000037600003860000406000041600004260000436000044600004560000476000048600004960000506000051600005260000536000054600005560000566000057600005860000596000060600006160000626000063600006460000656000066
- Amount recalled
- 424 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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