OmniDiagnost System
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- July 17, 2003
- Posted
- July 20, 2004
- Terminated
- January 12, 2005
- Recall Number
- Z-0874-03
- Quantity
- 52
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling of push button caps located on the control panel may not clearly identify the applied Source to Image distance (SID).
Distribution
The firm distributed devices to 81 hospitals and medical centers located throughout the U.S.
Lot / Code Info
OmniDiagnost User Interface PN 9896 000 59561, 9896 000 12381, 9896 000 58161; The firm utilizes a ''site number'' specific to each unit: 101599, 103055, 103058, 100520, 100873, 101152, 101154, 101676, 101962, 102164, 102582, 102977, 103050, 103051, 103052, 103055, 103058, 103218, 103219, 104012, 104577, 104858, 104934, 105324, 105394, 13124, 38351, 50428, 76596, 76944, 76948, 82655, 83871, 83958, 84441, 84850, 85163, 85165, 86113, 86303, 86326, 86339, 86340, 86485, 86486, 86549, 86965, 86977, 87164, X1707, X1747, 104857
Root Cause
Other
Action Taken
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.