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Terminated

CIOS ALPHA; image intensified fluoroscopic x-ray system

FDA Recall Z-0118-2016 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2015-08-17
Date Terminated2016-12-05
Product Quantity44

Reason for Recall

patient procedure interruption due to a potential system failure

Firm Action

Customer Safety Advisory Notice XP038/15/S, dated August 17, 2015, was sent to direct accounts to alert them to the issue and provide work-around instructions to avoid potential risks.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

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

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