Z-1404-2008

MEVATRON M-2 6300 Medical Linear Accelerator, Material Number: 09401316 with control console software...

Name: Z-1404-2008 MEVATRON M-2 6300 Medical Linear Accelerator, Material Number: 09401316 with control console software...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-01-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-01-11 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of MEVATRON M-2 6300 Medical Linear Accelerator, Material Number: 09401316 with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by... on 2008-01-11. The reason FDA records is "Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact". 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-1404-2008
Status: Terminated
Initiated: 2008-01-11
Posted: 2008-04-02
Terminated: 2011-05-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MEVATRON M-2 6300 Medical Linear Accelerator, Material Number: 09401316 with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
Root cause tag: software
FDA root cause: Software design
Action: This is a mandatory software upgrade for consignees. The firm's representatives have contacted consignees via Urgent Device Notification letters dated February 14, 2008, notifying them of the new update and making arrangements to install it.
Quantity in commerce: 1 unit
Distribution: Worldwide-USA including states of AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MS, MO, MN, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, and WY and countries of Angola, Australia, Austria,Belgium,Brazil,Canada,Chile,Colombia,Costa Rica, Croatia,Cyprus,The Czech Republic,Denmark,DPR of Korea,El Salvador,France,Germany,Greece,Hungary,India,Iran,Ireland,Italy,Japan,Jordan,Malaysia,Mexico, The Netherlands,New Zealand,Norway,P.R. China,Pakistan,Peru,Philippines,Poland,Portugal,Republic of Korea,Romania,Russian Fed.Saudi Arabia,Singapore,Slovakia,South Africa,Spain,Sweden,Taiwan,Thailand,Trinidad,Tobago,Turkey, U.A.E.,Ukraine, The United Kingdom, and Venezuela
Product codes and lots: Serial Number; 2703

Product code IYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)