Reported Mar 22, 2017 · Terminated
882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging…
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?
- 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
- Lot codes and dates
426 of 426 codes
600001360000256000029600003660000386000045600005160000656000006600007060000746000072600007860000816000083600008460000866000090600011360001276000173600017460001856000182600018860001836000187600018660002016000215600023660002346000246600029660003326000334600035160003686000370600038060000126000152634000960000116000024600017560000316000253600004260000526000030600000260000046000069600007660001426000004A600012260000166000158
- Amount recalled
- 1218 total
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
Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
This product could cause temporary or reversible health problems — stop using it.
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