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Terminated

Tube Stand for the Dynarad Phantom Mobile X-Ray System; Del Medical Systems, 11550 West King Street, Franklin Park, IL 60131

FDA Recall Z-0816-05 · Posted 2005-05-11

Recalling FirmDel Medical Systems Group
Recall StatusTerminated
Product CodeIYB
Date Initiated2005-03-10
Date Terminated2005-11-14
Product Quantity31 stands

Reason for Recall

The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. It the weld fails, the tubehead arm assembly could fall and contact the patient or operator.

Firm Action

Del Medical sent Field Correction Recall letters dated 3/10/05 to the direct accounts, informing them of the potential for a defective weld supporting the braket holding the locking cylinder assembly. If the weld fails, the tubehead arm assembly could potentially fall and contact the patient or operator. The accounts were requested to locate the affected systems and take them out of service until they are inspected and, if needed, repaired.

Root Cause

Other

Distribution Pattern

Nationwide, Mexico and Thailand.

Official Source

View FDA Recall →

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

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