GE OEC Medical Systems, Inc
04 رجب 1428 هـ الموافق 18 يوليو 2007 م
| Recalling Firm / Manufacturer |
GE OEC Medical Systems, Inc |
| Product |
OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah. |
| Code Information |
Serial numbers in the range of 86-0032 to 86-2161 |
| Reason of Recall |
X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures |
| Date Recall Initiated |
May 24, 2007 |
| Action |
Consignees were notified by letter on 05/24/2007 and advised that a service representative would be contacting them for installation of the required label and to provide them with an update to their user's manuals. Firm Initiated recall is ongoing. |
| Contact |
GE Healthcare
01 / 4600530 |
| Source of Information |
U.S. FDA |
| SFDA Comments |
SFDA urges all hospitals that have devices subjected to recall, to contact the company. |