Z-0974-04

VersaRad/Traumex General Radiographic System

Name: Z-0974-04 VersaRad/Traumex General Radiographic System
Creator: Fischer Imaging Corporation
Published: 2004-04-23
License: https://open.fda.gov/license/

Fischer Imaging Corp. / initiated 2004-04-23 / Terminated

FDA source

Fischer Imaging Corporation began a recall of VersaRad/Traumex General Radiographic System on 2004-04-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0974-04
Status: Terminated
Initiated: 2004-04-23
Posted: 2004-07-20
Terminated: 2012-03-13
Recalling firm: Fischer Imaging Corp.
Product: VersaRad/Traumex General Radiographic System.
Product code: IYB Tube Mount, X-Ray, Diagnostic
Reason for recall: 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.
FDA root cause: Other
Action: Consignees were notified by letter on 4/23/2004.
Quantity in commerce: 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.
Product codes and lots: All units.

Product code IYB

K880530Class ICeiling Mounted Radiographic System TraumexFischer Imaging Corp. / cleared 1988-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)