Electrophysiology Imaging System
FDA device recall Z-1526-05 · posted 2005-09-09 · Terminated
Recall details
- Recalling firm
- Fischer Imaging Corporation
- Reason for recall
- Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.
- Action taken
- Consignees were notified by certified letter on 04/27/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 20 units
- Distribution
- Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
- Date initiated
- 2005-04-28
- Date posted
- 2005-09-09
- Date terminated
- 2012-03-13
- Location
- Denver, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EP-X BIPLANE (K961207) | Fischer Imaging Corp. | 1996-08-20 |
| EP-X (K934481) | Fischer Imaging Corp. | 1993-11-03 |
| CSP (K912448) | Fischer Imaging Corp. | 1991-08-28 |