Reported Jun 12, 2013 · Terminated
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 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 SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
- Lot codes and dates
505 of 505 codes
Model # 882480Serial #'s: 400054400381400008940000904000091400009340000944000095400009840000994000100400010240001034000104400010540001064000107400010840001094000110400011140001124000113400011440001154000116400011740001184000119400012040001214000122400012340001244000125400012640001274000128400012940001304000132400013340001354000136400013740001384000139400014040001414000142400014340001444000145400014640001484000149400015140001524000153
- Amount recalled
- 505 units
Where it was sold
Why it was recalled
Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.
This product could cause temporary or reversible health problems — stop using it.
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