Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 718
FDA device recall Z-0068-06 · posted 2005-10-21 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The image balance center point correction algorithm used in CT image reconstruction may cause a disapperance or alteration of small circular anatomical structures that are both near the image center and perpendicular to the image plane. This artifact may lead to the misinterpretation of anatomy at the center of the image.
- Action taken
- The recalling firm sent a recall/field correction letter, dated August 18, 2005 to customers, notifying them of the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 19 devices
- Distribution
- The product was distributed to customers within the US and to foreign customers located in Canada, France, Thailand, South Africa, and Italy.
- Date initiated
- 2005-08-18
- Date posted
- 2005-10-21
- Date terminated
- 2008-10-29
- Location
- Cleveland, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI GXL (K042935) | Philips Medical Systems (Cleveland), Inc. | 2004-11-09 |