Recall Z-0162-04 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Medstone International Inc
URO PRO Plus Digital Urology Imaging System
| Date | Jul 20, 2004 (initiated Aug 11, 2003) |
| Status | Terminated |
| Reason | X-ray tube arm and collimator fell and fractured patient's ribs. |
| Root cause | Other |
| Action | An initial safety alert was sent to sites on 7/29/2003 to pre-announce repairs and advise them to not use the equipment. A second safety alert was sent on 8/11/03 to confirm repair dates. Repairs were completed 8/19,2003. |
| Quantity | 5 units |
| Distribution | NM, NV, WA, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.