Recall Z-2241-2012 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE OEC Medical Systems, Inc
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional ra
| Date | Aug 22, 2012 (initiated Apr 26, 2010) |
| Status | Terminated |
| Reason | GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation. |
| Root cause | Component change control |
| Action | No customer communication took place. On April 26, 2010, GE began opening service cases for field engineers to begin replacing the snubber boards. This action has been completed as of October 29, 2010. |
| Quantity | 845 units |
| Distribution | Worldwide and Nationwide (USA) distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Apr 17, 2002 |
| K022069 | OEC FLUOROTRAK 9800 PLUS Ge Oec Medical Systems, Sep 17, 2002 |
| K024012 | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Mar 20, 2003 |
| K041932 | OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM Ge Oec Medical Systems, Inc., Aug 18, 2004 |