Recall Z-1130-2007 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems, Inc
Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirato
| Date | Aug 7, 2007 (initiated May 18, 2007) |
| Status | Terminated |
| Reason | Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity. |
| Root cause | Other |
| Action | Consignees were notified by certified mail on 05/18/2007 and were told to stop using and to dispose of the affected probes. |
| Quantity | 67,625 units |
| Distribution | Worldwide, including USA, Canada and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960330 | INSTATRAK Visualization Technology, Inc., Apr 8, 1996 |