ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Recall Z-1212-2017 · Posted None
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2017-01-25
Date Terminated2018-10-01
Product Quantity194 systems
Reason for Recall
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
Firm Action
Siemens mailed a Customer Safety Advisory Notice (CSAN) dated February 7, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Siemens will contact customers to arrange a date for the installation of the software update.
Root Cause
Device Design
Distribution Pattern
United States distribution
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.