Recall Z-0952-03 ยท IYE Accelerator, Linear, Medical
Standard Imaging Inc.
Exradin A12 Ionization Chamber
| Date | Jun 27, 2003 (initiated May 28, 2003) |
| Status | Terminated |
| Reason | Ionization chambers, used for checking x-ray equipment, were experiencing some drift from the tested calibration factors. |
| Root cause | Process design |
| Action | The consignees were telephoned on May 28, 2003 and informed of the problem and recall, and sent a recall letter, dated May 28, 2003, requesting the return of the product. |
| Quantity | 25 units |
| Distribution | The product was shipped to 24 hospitals located nationwide in the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.