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Terminated

URO PRO Plus Digital Urology Imaging System

FDA Recall Z-0162-04 · Posted 2004-07-20

Recalling FirmMedstone International Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2003-08-11
Date Terminated2003-11-26
Product Quantity5 units

Reason for Recall

X-ray tube arm and collimator fell and fractured patient's ribs.

Firm Action

An initial safety alert was sent to sites on 7/29/2003 to pre-announce repairs and advise them to not use the equipment. A second safety alert was sent on 8/11/03 to confirm repair dates. Repairs were completed 8/19,2003.

Root Cause

Other

Distribution Pattern

NM, NV, WA, CA.

Official Source

View FDA Recall →

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

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