Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 6
FDA device recall Z-0013-2007 · posted 2007-09-26 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.
- Action taken
- The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 70
- Distribution
- Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.
- Date initiated
- 2006-11-06
- Date posted
- 2007-09-26
- Date terminated
- 2010-10-05
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI GXL (K042935) | Philips Medical Systems (Cleveland), Inc. | 2004-11-09 |
| GEMINI PET/CT IMAGING SYSTEM (K041955) | Philips Medical Systems (Cleveland), Inc. | 2004-07-29 |