Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device
This recall has been terminated (originally issued March 29, 2006).
- Company
- Toshiba American Med Sys Inc
- Recall Initiated
- February 23, 2006
- Posted
- March 29, 2006
- Terminated
- February 29, 2012
- Recall Number
- Z-0533-06
- Quantity
- 5
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
Reason for Recall
When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiring images or will continue to acquire blank images. The remote console will lock-up upon release of the hand switch. The operator must reboot the system. This will result in the loss of the images acquired during the contrast portion of the study.
Distribution
Nationwide to AZ, CA, FL, MT, & PA
Lot / Code Info
Serial numbers: D4622390, D4622394, D4623349, D4612382, & D5512402
Root Cause
Other
Action Taken
Recall letter to be sent to to customers of affected devices beginning February 23, 2006. Corrected software to be issued by Toshiba America Medical Systems Inc, for all affected devices.