Company Siemens Medical Solutions USA, Inc
Date of Enforcement Report 5/28/2014
Class lI:
PRODUCT
550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer.
Recall Number Z-1645-2014
REASON
Table may lose calibration during patient treatment, which may cause the possibility of mistreatment.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 4/12014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
120
DISTRIBUTION
Nationwide
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