Reported Feb 12, 2014 · Terminated
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470,…
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?
6 of 6 products
| Model / number | Product as published |
|---|---|
882412 | TruFlight Select |
882438 | GEMINI TF PET/CT16 |
882470 | GEMINI TF PET/CT 64 |
882471 | GEMINI TF Ready |
882473 | & GEMINI TF Big Bore |
882476 | ) |
- Lot codes and dates
382 of 382 codes
Model #882412Serial #'s:147011470214704147051470614707147081470914710 & 14711. Model #882438Serial #'s:1700217003170041700517006170071700817009170101701117012170131701417015170171701817019170211702217023170241702517026 & 17028. Model #882470Serial #'s: 700370047005700670087009701070117014701570177019702070217022702470257026703170347035703670397043704570497050
- Amount recalled
- 386 units
Where it was sold
Why it was recalled
The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.
This product could cause temporary or reversible health problems — stop using it.
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