Recall Z-1403-05 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Biosound Esaote, Inc.
MyLab25 Ultrasound Imaging System; Model 9807300002.
| Date | Aug 25, 2005 (initiated May 6, 2005) |
| Status | Terminated |
| Reason | Data may be corrupted upon re-opening archived files. |
| Root cause | Other |
| Action | U.S. distributors were notified via recall letter dated 5/2/05 and U.S. customers were notified via letter dated 5/6/05. Canadian customer were notified via letter dated 5/13/05 and Puerto Rico distributor and customers were ntofied on 5/9/05. The firm is installing new software in the field. |
| Quantity | 10 |
| Distribution | Nationwide, Canada and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040596 | ULTRASOUND IMAGING SYSTEM, MODEL 7300 Esaote, S.p.A., Mar 31, 2004 |