Xcelera System, image processing, radiological.
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- April 15, 2004
- Posted
- July 20, 2004
- Terminated
- April 11, 2005
- Recall Number
- Z-0973-04
- Quantity
- 56 units
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the image data to be erased from the long term archive.
Distribution
Devices were distributed to hospitals and medical centers throughout the US.
Lot / Code Info
Part numbers: 9896 050 73251XC1.1L1 Software binder; 9896 050 73252XC1.1L1 Sofware binder + SP2
Root Cause
Other
Action Taken
On 4/15/04 the firm sent letters to customers advising of the problem and that a service representative will visit and conduct a software upgrade.
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