Recall Z-2203-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Toshiba American Medical Systems Inc
Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound
| Date | May 19, 2011 (initiated Jan 6, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 image |
| Quantity | 28 |
| Distribution | Nationwide Distribution -- Including states of IA, MT, PA, CA, OR, GA, LA, OH, TX, MA, OH, WI, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090158 | APLIO ARTIDA V2.0 SSH-880CV Toshiba America Medical Systems, In.C, Feb 6, 2009 |