—#69045

Product

Oncor Avante-Garde 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

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031764
Affected lot / code info: Serial Numbers: 3576 3938 70-4283 3738 3817 3987 3988 4095 70-4368 4016 3904 3926 4079 4082 70-4077 70-4113 70-4197 3905 3934 3852 3737 3758 3856 3891 3929 3937 70-4163 3895 3896 4049 70-4201 70-4184 5038 70-4213 70-4223 5012 70-4311 3932 3739 3806 3884 3912 3941 70-4297 70-4314 and 70-4217

Why it was recalled

Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2008-01-11
Posted by FDA: 2008-04-02
Terminated: 2011-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69045. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.