Reported Feb 14, 2018 · Terminated
BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma camera for Single Photon Emission Computed…
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 Product UsageBrightView 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 an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView 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. The BrightView XCT imaging system should only be used by trained healthcare professionals
- Lot codes and dates
- Brightview
- XCT Model 882482 Serial Numbers
431 of 431 codes
6000241600029060002916000292600030660002896000304600037460002376000317600023560003186000167600019460002296000391600035260002206000054600006060001956000204600020660002956000203600004360000826000402600005660000266000228600017160003556000089600003360000536000094600009360001656000199600034960002196000396600016311000021600032560000226000015600002060000476000130600018460003306000147600012360000776000128600025160000666000131
- 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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