Reported Nov 6, 2013 · Terminated
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView…
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 is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data.
- Lot codes and dates
- The following model and serial
- numbers are affected by this recallModel
- Number882454
- Serial Number(s)
1100002111000082and 11000111
- Model Number882482
- Serial Number(s)
366 of 366 codes
600000260000036000004A6000005600001060000116000012600001360000156000016600001760000186000019600002060000226000023600002460000256000026600002760000286000029600003060000316000033600003660000376000038600004060000416000004260000436000044600004560000476000048600004960000506000051600005260000536000054600005560000566000058600005960000606000061600006260000636000064600006560000666000067600006960000706000071600007260000736000074
- Amount recalled
- 371 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position.
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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