MyLab30CV Ultrasound Imaging System; model 9807300001.
FDA device recall Z-1402-05 · posted 2005-08-25 · Terminated
Recall details
- Recalling firm
- Biosound Esaote, Inc.
- Reason for recall
- Data may be corrupted upon re-opening archived files.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 176
- Distribution
- Nationwide, Canada and Venezuela.
- Date initiated
- 2005-05-06
- Date posted
- 2005-08-25
- Date terminated
- 2005-10-25
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRASOUND IMAGING SYSTEM, MODEL 7300 (K040596) | Esaote, S.p.A. | 2004-03-31 |