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
This recall has been terminated (originally issued April 2, 2008).
- Recall Initiated
- January 11, 2008
- Posted
- April 2, 2008
- Terminated
- May 6, 2011
- Recall Number
- Z-1398-2008
- Quantity
- 31 units
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
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
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
Root Cause
Software design
Action Taken
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.