—#69044

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

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K993425
Affected lot / code info: 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

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 #69044. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.