The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder
FDA device recall Z-1939-2009 · posted 2009-09-17 · Terminated
Recall details
- Recalling firm
- Verathon, Inc.
- Reason for recall
- Three specific issues are being addressed: 1. Calculation and use of an incorrect year in dates after 12/31/2009. 2. Double scans, continuous scans, and double printing. 3. Calibration sensitivity.
- Action taken
- U.S. customers (including Government) were sent a post card on or about 5/18/2009 and were called about the upgrade. Units are to be upgraded by the customers using an online tool called ScanPoint. Customers may elect to return their units to the firm for upgrading. Canadian customers were phoned by Verathon. For foreign units sold and distributed through one of the recalling firm's related firms, Service Bulletin SB-0014 was sent to the distributors located in The Netherlands, United Kingdom, and Australia. Contact Verathon Customer Care at 1-800-331-2313 if you have any questions.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 1,978
- Distribution
- Worldwide - US, Canada, Malaysia, Hong Kong, Singapore, Argentina, New Zealand, Barbados, Dominican Republic, and Costa Rica.
- Date initiated
- 2009-05-18
- Date posted
- 2009-09-17
- Date terminated
- 2010-10-07
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLADDERSCAN BVI 9400 ULTRASOUND (K071217) | Verathon Incorporated | 2007-05-17 |