Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/13/2011
Class ll:
PRODUCT
Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system. a) Part No. 081239953, b) SPI Patch, Part No. 08164365. Recall # Z-1834-2011
REASON
Software defect problem is repeatable..
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter beginning November 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
CA, KY, MI, NJ, TN, Canada and Mexico
