GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator
FDA device recall Z-1304-06 · posted 2006-09-22 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- Reason for recall
- Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept the entire cross section of the useful beam
- Action taken
- An Important Notice for Precision 500D, dated 11/24/2005 was hand delivered to all customers beginning 05/15/06, by GE field service engineers at the time they were to perform the correction to the device.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 1,289
- Distribution
- Worldwide, including USA, Puerto Rico, Canada, France, Germany, Indonesia, Italy, Japan, Jordan, Kuwait, Macedonia, Panama, Russia, Saudi Arabia, Singapore, and United Kingdom.
- Date initiated
- 2006-05-15
- Date posted
- 2006-09-22
- Date terminated
- 2007-05-25
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPEDIO 500D R&F X-RAY SYSTEM (K011624) | GE Medical Systems | 2001-06-08 |