Z-1486-2012

Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand...

Name: Z-1486-2012 Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand...
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-04-03
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-04-03 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator... on 2012-04-03. The reason FDA records is "SIEMENS has received reports where a dropping down of the 550 TxT" Treatment Table was observed while the table was being moved downwards during operation by means of the hand control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1486-2012
Status: Terminated
Initiated: 2012-04-03
Posted: 2012-05-03
Terminated: 2013-03-14
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478. 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 received reports where a dropping down of the 550 TxT" Treatment Table was observed while the table was being moved downwards during operation by means of the hand control.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent Customer Information letters to all affected customers beginning April 3, 2012 via Siemens Field Service Engineers. The letter identified the affected product, what is the issue and what has Siemens done to address this issue. The letter included an Update Instructions TH006/12/S - TxT Table Software Update VD00A. SIEMENS has arranged for a modification of the affected system. A SIEMENS Service Representative will ensure that the new software version VD00A is installed on affected system. The letter instructs customer to please include this Customer Information in their Digital Linear Accelerator System Owner Manual chapter Safety Advisory Letters where it should remain.
Quantity in commerce: 624 active devices
Distribution: Worldwide Distribution - USA (nationwide) including P.R and the countries of: Africa, Angola, Argentina, Australia, Austria, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Russian Federation, Saudi Arabia, Serbia, South Thailand, Sri Lanka, Spain, Switzerland, Trinidad, Tobago, Turkey, Ukraine and United Kingdom, .
Product codes and lots: System IVK no. Component Component IVK Ser # ARTISTE MV system 8139789 550 TxT table 7346534 d1894 ONCOR Expression 7360717 550 TxT table 7346534 d1894 ONCOR Impression 5857912 550 TxT table 7346534 d1894 Plus ONCOR Impression 5857920 550 TxT table 7346534 d1894 ONCOR Avant Garde 5863472 550 TxT table 7346534 d1894 PRIMUS HI 4504200 550 TxT table 7346534 d1894 PRIMUS Mid-Energy 1940035 550 TxT table 7346534 d1894

Product code IYE

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)