Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

VersaRad Generator

FDA Recall Z-0787-05 · Posted 2005-05-03

Recalling FirmFischer Imaging Corporation
Recall StatusTerminated
Product CodeIYB
Date Initiated2004-09-30
Date Terminated2012-03-13
Product Quantity38 units

Reason for Recall

Some VersaRad Systems have a faulty weld that may result in oil leakage.

Firm Action

Customers were sent notification letters.

Root Cause

Other

Distribution Pattern

Domestic distribution: ... International distribution: Germany, Greece, Italy, Kuwait, Spain, Sweden, Switzerland. No VA or military facilities.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K880530CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEXFischer Imaging Corp. · 1988-03-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑