FDA Medical Device Recalls (openFDA)
Fischer Imaging Corporation: Electrophysiology Imaging System
- Recall number
- Z-1526-05
- Recalling firm
- Fischer Imaging Corporation
- Product
- Electrophysiology Imaging System
- Status
- Terminated
- Initiated
- 2005-04-28
- Posted
- 2005-09-09
- Terminated
- 2012-03-13
- Reason
- Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.
- Root cause
- Other
- Action
- Consignees were notified by certified letter on 04/27/2005.
- Quantity
- 20 units
- Distribution
- Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
- Lot, serial or model codes
- Model EPX 2, Product Number 93950G-1
- 510(k) numbers
- ["K912448","K934481","K961207"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1418957
- Firm city
- Denver
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28