GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protectio
FDA device recall Z-2241-2012 · posted 2012-08-22 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 845 units
- Distribution
- Worldwide and Nationwide (USA) distribution.
- Date initiated
- 2010-04-26
- Date posted
- 2012-08-22
- Date terminated
- 2012-08-22
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM (K041932) | Ge Oec Medical Systems, Inc. | 2004-08-18 |
| OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM (K024012) | Ge Oec Medical Systems | 2003-03-20 |
| OEC FLUOROTRAK 9800 PLUS (K022069) | Ge Oec Medical Systems | 2002-09-17 |
| OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM (K021049) | Ge Oec Medical Systems | 2002-04-17 |