PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Recall Z-2095-2013 · Posted 2013-08-26
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2013-07-18
Date Terminated2014-11-24
Product Quantity179 active devices.
Reason for Recall
Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT treatment tabletop. Due to a manufacturing error, the screws holding the side rails in position on the tabletop might break off.
Firm Action
Siemens released Updated Instruction containing the Medical Device Correction Field Safety Notice of Improvement letter, which was delivered by the Siemens Customer Service Group to all affected customers. The release of this UI TH002/12/S to distribute the update instruction began on July 18, 2013. This document includes completion protocol, which will be completed at each facility and returned to Siemens. A copy of the notification should be kept in the Digital Linear Accelerator System owners manual under Safety Advisory letters.
UPDATE: a secnd update intruction, TH003/12/S has been released to begin the replcement of tabletops identified through the inspection carried out through TH002/12/S.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of NJ, IN, PA, FL, OH, MN, MO, CA, AL, NE MI, LA. and countries of:Argentina, China, South Africa, Pakistan, Spain, Switzerland, Italy, Algeria, Croatia, Turkey, Canada, Germany, France, Poland, Japan, Russian Federation. Lebanon, Egypt, Slovakia, Latvia, Kenya, Brazil, Kuwait, Saudi Arabia, Greece, Belgium, Taiwan, Portugal.
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.