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Terminated

STS-T Mobile x-ray system used with the STS-T lithotripter.

FDA Recall Z-0884-04 · Posted 2004-08-28

Recalling FirmMedstone International Inc
Recall StatusTerminated
Date Initiated2004-06-11
Date Terminated2004-09-01
Product Quantity30 unites

Reason for Recall

Units are defective in that the identification and certification labels were inadequate or missing. The beam limiting device was not appropriate for general purpose radiographic procedures and the beam limiting device could ot collimate down to 125 square centimeters or less as required.

Firm Action

Field Service Engineers will install a dual fixed-size colimator and console label and a new user manual will be provided.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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