GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray
FDA device recall Z-2199-2015 · posted 2015-07-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
- Action taken
- On 7/6/2015 the firm sent Field Safety Notices to their customers.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 44 Units
- Distribution
- Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerla
- Date initiated
- 2015-07-01
- Date posted
- 2015-07-22
- Date terminated
- 2018-06-26
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI CONDOR (K081135) | Philips Medical Systems (Cleveland), Inc. | 2008-04-29 |