Siemens Medical Solutions USA, Inc Coherence Therapist System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147667 Medical charged-particle radiation therapy system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Coherence Therapist System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147667 Medical charged-particle radiation therapy system.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial numbers associated with RTT2.0 and RTT2.1
Products Sold
Serial numbers associated with RTT2.0 and RTT2.1
Siemens Medical Solutions USA, Inc is recalling Coherence Therapist System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2. due to Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026