PRIMEVIEW 3i System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7341428
FDA device recall Z-0092-2009 · posted 2008-10-16 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Action taken
- Service calibration inspection/correction Update instructions TH038/07/S was issued on 11/06/2007 to all customers. The instructions identified the affected products, stated the reason for the update, and listed the steps to update the software. Customer notification was also issued. Software patch planned for release in June 2008.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 13 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2007-11-06
- Date posted
- 2008-10-16
- Date terminated
- 2010-12-18
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |