ARTISTE/RT Therapist v4.2 and/or Oncologist v4.2 systems. Manufactured by Siemens AG, Medical Solutions, Kemnath, Germany. Delivery of X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall Z-2977-2011 · Posted 2011-08-10
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-06-03
Date Terminated2012-03-30
Product Quantity121 devices
Reason for Recall
A potential safety rick related to transferring reference images for offset calculation between a syngo RT Therapist v 4.2 or a syngo RT Oncologist 4.2 and other versions of the COHERENCE/syn go RT Therapist or Oncologist or vice versa. An incorrect offset may be applied for patient positioning and result in dose being delivered to the wrong location.
Firm Action
Siemens sent an "URGENT: MEDICAL DEVICE CORRECTION/CUSTOMER SAFETY ADVISORY NOTICE" letter dated June 3, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers.
The letter provides preventive measure instructions for customers to use until an update for the system is available.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of CA, FL, NC, NY, OH, PA, SD, UT, and WI and countries of Australia, Belgium, Croatia, Czech Republic, Germany, India, Ireland, Japan, Poland, Saudi Arabia, South Africa, Spain, Sweden, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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