Recall Z-0068-06 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.)
| Date | Oct 21, 2005 (initiated Aug 18, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The recalling firm sent a recall/field correction letter, dated August 18, 2005 to customers, notifying them of the problem. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042935 | GEMINI GXL Philips Medical Systems (Cleveland), Inc., Nov 9, 2004 |