Xcelera R1.2 Cardiology image and information management solution software.
FDA Recall Z-0640-05 · Posted 2005-03-18
Recall StatusTerminated
Product CodeLLZ
Date Initiated2004-12-21
Date Terminated2006-02-10
Product Quantity33
Reason for Recall
Loss of image data from image repository and archive requiring patients to undergo repeat imaging.
Firm Action
The firm notified hospitals via letter sent 12/21/2004 stating the service organization will perform onsite upgrades.
Root Cause
Other
Distribution Pattern
Hospitals and medical centers throughout the US.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.