Device Recall Toshiba DRAD3000E FPD Wireless system 의 리콜

Recall

73064

Class 2

Z-1175-2016

2016-01-14

2016-03-21

Terminated

United States

2017-02-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142948

When a user performed radiography using the wireless fpd, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. it also indicated to select the "ok" button to re-acquire the image data or to select the¿'cancel" button to cancel the re-acquisition. as instructed the user selected "ok" and the same message window appeared. this same operation was repeated several times with the identical result - no image. finally, the user selected "cancel" and the re-acquisition was terminated.

Toshiba's planned action: 1."Toshiba America Medical Systems, Inc. (TAMS) will advise contact customers to stop using the system if any abnormalities are found using the system. 2. TAMS will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that TAMS will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. TAMS will implement this CAP by June 30, 2016. Customers with questions were advised to call 301-796-5910. For questions regarding this recall call 714-730-5000.