GE OEC Medical Systems, Inc
04 رجب 1428 هـ الموافق 18 يوليو 2007 م
| Recalling Firm / Manufacturer |
GE OEC Medical Systems, Inc |
| Product |
GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. |
| Code Information |
Serial numbers: P4-0665-R, P4-0666-L, P4-0679-R, P4-0685-L, P4-0686-L, P4-0694-R, P4-0696-L, P4-0701-R, P4-0702-R, P4-0717-L, P4-0723-R, P4-0730-L, P6-0695-R, P6-0699-R, P6-0700-R, P6-0709-R, P6-0711-L, P6-0712-R, P6-0714-L, P6-0715-L, P6-0718-R, P6-0719-L, P6-0721-L, P6-0724-R, P6-0726-L. |
| Reason of Recall |
X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma. |
| Date Recall Initiated |
June 12, 2007 |
| Action |
Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems. 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. |