Company: Siemens Medical Solutions, USA, Inc
Date of Enforcement Report 5/7/2008
Class:ll
PRODUCT
a) Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle
radiation therapy system with software version 2.1, Recall # Z-0971-2008;
b) Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle
radiation therapy system with software version 2.1, Recall # Z-0972-2008;
c) Siemens Coherence Impression Therapist system, Part No: 7341410, medical
charged-particle radiation therapy system with software version 2.1,
Recall # Z-0973-2008;
d) Siemens Primeview 3i medical charged-particle radiation therapy system,
Part No: 7341428, with software version 3i, Recall # Z-0975-2008;
e) Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy
system, Part No: 7345411, Recall # Z-0975-2008;
f) Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation
therapy system, Part No: 7345429, Recall # Z-0976-2008;
g) Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation
therapy system, Part No: 7345437, Recall # Z-0977-2008;
h) Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy
system, Part No: 8139839, with software version 2.1, Recall # Z-0978-2008;
i) Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system,
Part No: 8139487, with software version 3i 2.0, Recall # Z-0979-2008;
j) Siemens Coherence Therapist 2.1 medical charged-particle radiation therapy system,
Part No: 8147667, with software version 2, Recall # Z-0980-2008;
k) Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part
No: 8147675, with software version 3i, Recall # Z-0981-2008
REASON
Image Orientation Incorrect (Image Shifts) – 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference image will shift.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Concord, CA, by letter on October 3, 2007. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
118 units
DISTRIBUTION
Nationwide and Internationally
