Reported Apr 12, 2017 · Terminated
BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector…
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 SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
- Lot codes and dates
84 of 84 codes
400000840002874000497400036440003464000557400042340000884000029400063140003394000072400064340006404000420400054340000104000282400021640004154000208400032240004064000434400024140000554000117400020040001384000352400050940003624000598400043340001784000473400027140003574000258400006040005284000099400019240000794000010140003104000214400067140000504000349400065840003084000215400038440002634000074400025540006334000098A4000251
- Amount recalled
- 84 systems
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
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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