Company:Siemens Medical Solutions USA.
Date of Enforcement Report 8/27/2008
Class:ll

PRODUCT
Medical charged-particle radiation therapy system. Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.0 and Oncologist R2.0. Product update, TH 030//07/S. The COHERENCE Therapist R2.0 software numbers are: 7358299, 7360857, and 8141835 and applies only to those parts used with the following devices: Coherence AG Therapist; Coherence Therapist System; Coherence Impression Therapist; PRIMEVIEW 3i; AG Therapist 3rd party V&R; Coherence Therapist 2.0 and PRIMEVIEW 3i 2.0; Recall # Z-1769-2008

REASON
A image issue: a complaint that images viewed in the device may shift, which could result in mistreatment.

RECALLING FIRM/MANUFACTURER
A image issue: a complaint that images viewed in the device may shift, which could result in mistreatment.

VOLUME OF PRODUCT IN COMMERCE
359 units

DISTRIBUTION
Nationwide and Internationally