Celesteion PCA-9000A/2 PET/CT System
Recall
- Recall Number
- Z-0005-2016
- Event Number
- 71763
- Firm
- Toshiba American Medical Systems Inc
- FEI Number
- 2020563
- Product Code
- KPS
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 8, 2015
- Posted
- October 7, 2015
- Terminated
- December 3, 2015
- Address
- 2441 Michelle Dr PO Box 2068, Tustin, CA, 92780-7047
Description
Celesteion PCA-9000A/2 PET/CT System
It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.
Planned Action by Toshiba Medical America Systems to address the defect: a. A notification will be sent to the customer with affected system in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on the system to prevent this occurrence from happening. The consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. The customer will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on their systems. If you have any questions please contact your local Toshiba Representative at (800) 521-1968.
US Distribution to the state of Nevada.
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