FDA Device

Coherence AG Therapist Part number 5863506, equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1 Medical charged-particle radiation therapy system.

Hazard

Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.

What You Should Do

Remedy

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.

Products

Coherence AG Therapist Part number 5863506, equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1 Medical charged-particle radiation therapy system.
Brand
Siemens Medical Solutions USA, Inc
UPC
Serial numbers associated with RTT2.0 and RTT2.1

Units Affected

14 units.