FDA Recall
Terminated
Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139839 Medical charged-particle radiation therapy system.
Recall: Z-0096-2009
·
Initiated November 6, 2007
Recall
- Recall Number
- Z-0096-2009
- Event Number
- 48432
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2937457
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 6, 2007
- Posted
- October 16, 2008
- Terminated
- December 18, 2010
- Address
- 4040 Nelson Ave, Concord, CA, 94520-1200
Description
Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139839 Medical charged-particle radiation therapy system.
Reason
Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
Action
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.
Distribution
Worldwide Distribution
Quantity
59 units