Device Recall Toshiba Celesteion PCA9000A/2 PET/CT System 의 리콜

Recall

71763

Class 2

Z-0005-2016

2015-05-08

2015-10-07

Terminated

United States

2015-12-03

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138996

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.