Z-0787-05

VersaRad Generator

Name: Z-0787-05 VersaRad Generator
Creator: Fischer Imaging Corporation
Published: 2004-09-30
License: https://open.fda.gov/license/

Fischer Imaging Corp. / initiated 2004-09-30 / Terminated / root cause: manufacturing process

FDA source

Fischer Imaging Corporation began a recall of VersaRad Generator on 2004-09-30. The reason FDA records is "Some VersaRad Systems have a faulty weld that may result in oil leakage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0787-05
Status: Terminated
Initiated: 2004-09-30
Posted: 2005-05-03
Terminated: 2012-03-13
Recalling firm: Fischer Imaging Corp.
Product: VersaRad Generator
Product code: IYB Tube Mount, X-Ray, Diagnostic
Reason for recall: Some VersaRad Systems have a faulty weld that may result in oil leakage.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Customers were sent notification letters.
Quantity in commerce: 38 units
Distribution: Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA or military facilities.
Product codes and lots: Generator S/N''s: 9918-0704-002; 9918-0804-003; 9918-0804-007; 9918-0804-005; 9918-0204-001; 9918-0304-001; 9918-0304-003; 9918-03304-004; 9918-0505-002; 9918-0604-001; 9918-0604-003; 9918-0604-006; 9918-0704-001; 9918-0704-003; 9918-0704-004; 9918-0704-005; 9918-0803-002; 9918-0804-002; 9918-0903-002; 9918-1003-001; 9918-1203-002; 9918-0604-007; 9918-0804-004; 9918-0404-002; 9918-0803-001; 9918-0504-003; 0304-002; 0404-003; 0504-004; 9918-0604-005; 9918-0903-001; 9918-0404-001; 9918-0604-002; 9918-0504-001; 9918-0804-001; 9918-1103-001; 9918-1203-001; 9918-0604-004.

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)