OmniDiagnost System
FDA Recall Z-0874-03 · Posted 2004-07-20
Recall StatusTerminated
Date Initiated2003-07-17
Date Terminated2005-01-12
Product Quantity52
Reason for Recall
Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).
Firm Action
On 7/17/03 the firm issued a letter dated June 12, 2003 to their customers advising that service personnel will visit the consignees and replace the buttons.
Root Cause
Other
Distribution Pattern
The firm distributed devices to 81 hospitals and medical centers located throughout the U.S.
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.