Device Recall SSH880CV Aplio Artida 의 리콜

Recall

55543

Class 2

Z-2203-2011

2010-01-06

2011-05-19

Terminated

United States

2012-04-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91087

Toshiba america medical systems (tams) has become aware that the flex m software has reversed left and right annotation and post flex m measurement error, which may result in incorrect values.

The recall communication was initiated on 1/6/10 with Toshiba forwarding an Urgent: Medical Device Correction letter with attached Customer Notification Reply Form (via US Postal Service for US Customers) to all customers who purchased the FLEX-M mode on Aplio Artida Diagnostic Ultrasound System. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to avoid performing M image measurement using images saved in FLEX-M mode until the corrective action is completed. If customers need to perform measurement for images saved in FLEX-M mode, they were instructed to use manual calibration. Customers were instructed to note that even though the corrective action is taken, the existing saved images (saved images before the corrective action is taken) are not modified. Therefore, when referring to the measured values on the images which are saved in FLEX-M mode before the corrective action is taken, customers were instructed to carefully handle the measurements results because they may be incorrect. Customers were instructed to complete the attached form and fax it to the toll free number at the top of the form. The form can also be sent via e-mail to raffairs@tams.com. If customers have any questions regarding the medical device correction letter, they can contact the Director of Regulatory Affairs at (800) 421-1968 or their local Toshiba representative.