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Terminated

OptiVantage DH Power Injection System.

FDA Recall Z-0288-2007 · Posted 2006-12-16

Recalling FirmMallinckrodt Inc
Recall StatusTerminated
Product CodeCXT
Date Initiated2006-11-07
Date Terminated2007-07-21
Product Quantity1348 devices.

Reason for Recall

The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired.

Firm Action

The recalling firm sent a letter dated 11/7/2006 to all consignees.

Root Cause

Other

Distribution Pattern

Worldwide distribution ---- including USA and countries of Australia, Belgium, Brazil, Canada, Chile, Columbia, Denmark, Mexico, Panama, Puerto Rico, Singapore and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042744OPTIV ANTAGE DH POWER INJECTION SYSTEMMallinckrodt Inc., Liebel-Flarsheim Business · 2004-11-30

Official Source

View FDA Recall →

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

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