Reported Mar 6, 2013 · Terminated
Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 -…
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?
The affected GEMINI systems are identified with the following Serial Numbers
4 of 4 products
| Model / number | Product as published |
|---|---|
882412 | GEMINI LXL , Serial Numbers: 14702 and 14707 |
882470 | GEMINI TF 16 , Serial Numbers: 7129, 7121, 7123, 7128, 7096, 7133, 7185, 7187, 7226, and 7220 |
882473 | GEMINI TF 16, , Serial Numbers: 7150, and and 7237 |
882471 | GEMINI TF 64, , Serial Numbers: 7103, 7126, 7132, 7158, 7160, 7164, 7175, 7178, 7179, 7218, 7229, 7221, 7245, 7550, 7255, and 7256. |
- Amount recalled
- 30 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was identified by the firm whereby these generated datasets are 'flipped' and incorrectly labeled left-to-right when the are saved to disk. If the flipped Intensity Project
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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