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Terminated

VersaRad/Traumex General Radiographic System.

FDA Recall Z-0974-04 · Posted 2004-07-20

Recalling FirmFischer Imaging Corporation
Recall StatusTerminated
Product CodeIYB
Date Initiated2004-04-23
Date Terminated2012-03-13
Product Quantity138 units

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.

Firm Action

Consignees were notified by letter on 4/23/2004.

Root Cause

Other

Distribution Pattern

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.

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.

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