FDA Medical Device Recalls (openFDA)
Fischer Imaging Corporation: VersaRad/Traumex General Radiographic System.
- Recall number
- Z-0974-04
- Recalling firm
- Fischer Imaging Corporation
- Product
- VersaRad/Traumex General Radiographic System.
- Status
- Terminated
- Initiated
- 2004-04-23
- Posted
- 2004-07-20
- Terminated
- 2012-03-13
- Reason
- If two of the four T-nuts that connect the transverse rail to the ceiling rail fail, the 'U' arm and transverse rails could fall and cause serious injury.
- Root cause
- Other
- Action
- Consignees were notified by letter on 4/23/2004.
- Quantity
- 138 units
- Distribution
- Nationwide, including VA facilities in MI, MN and VT. No military consignees. Foreign distribution to Australia, Canada, Denmark, Italy, Korea, Netherlands, Norway, Sweden, United Kingdom.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K880530"]
- PMA numbers
- not on file
- Product code
- IYB
- 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