Z-1398-2008

Oncor Impression Medical Linear Accelerator, Material Number : 5857920, with control console software...

Name: Z-1398-2008 Oncor Impression Medical Linear Accelerator, Material Number : 5857920, 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 Oncor Impression Medical Linear Accelerator, Material Number : 5857920, 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-1398-2008
Status: Terminated
Initiated: 2008-01-11
Posted: 2008-04-02
Terminated: 2011-05-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Oncor Impression Medical Linear Accelerator, Material Number : 5857920, 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: 31 units
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 numbers; 4078 70-4143 70-4257 3878 70-4344 70-4207 70-4235 4021 70-4296 70-4165 70-4167 3729 5022 5035 5074 3811 3845 5108 70-4238 70-4386 3894 4048 70-4276 70-4277 70-4281 70-4083 3974 3962 3973 70-4152 and 3883

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