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 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah |
| Code Information |
Serial Numbers: 7315PU5, 7372PU6, 7384PU1, 7385PU8, 7389PU0, 7390PU8, 7393PU2, 7398PU1, 7398PU1, 7399PU9, 7702PU4, 7720PU6, 7721PU4, 7724PU8, 7725PU5, 7726PU3, 7728PU9, 7729PU7, 7732PU1, 7733PU9, 7734PU7.7747PU9. |
| 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. |