Z-2095-2013Class II

PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT...

Name: Z-2095-2013 PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-07-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-07-18 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2013-07-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2095-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-18
Posted: 2013-08-26
Terminated: 2014-11-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 179 active devices.
Distribution: 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.
Product codes and lots: ONCOR, PRIMUS and ARTISTE Lican systems with tabletop component: Tabletop, 550TxT, TT-A 08632296* Tabletop, 550TxT, TT-S 10046140

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2095-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2095-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code IYE

K993425Class IIPrimusSiemens Medical Solutions USA, Inc. / cleared 1999-11-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)