GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.
FDA device recall Z-1709-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- OEC Medical Systems, Inc
- Reason for recall
- Secondary collimator filters may be missing on certain x-ray units. It was discovered that the secondary collimator filter on some OEC 9600 C-arms was omitted when a collimator assembly was replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to Maximum Entrance Exposure Rate (EER) unless the maximum EE
- Action taken
- Domestic customer notification letters were sent via certified mail on 07/02/2008. They were advised to have the Maximum EER assessed and to discontinue use if the maximum limits were exceeded.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 660 units
- Distribution
- Nationwide Distribution including states of CA, FL, MS, and TX.
- Date initiated
- 2008-07-02
- Date posted
- 2008-09-20
- Date terminated
- 2009-01-20
- 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 |
|---|---|---|
| SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM (K963952) | Ge Dec Medical Systems | 1996-12-23 |