—#66449

Product

Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Model Number 5863472, Serial Numbers 3737 3738 3739 3758 3806 3817 3852 3856 3884 3891 3895 3896 3904 3905 3912 3926 3929 3934 3937 3938 3944 3987 3988 4016 4049 4079 4082 4095 70-4077 70-4113 70-4163 70-4168 70-4169 70-4184 70-4188 70-4197 70-4201 70-4213 70-4217 70-4223 70-4283 70-4291 70-4297 70-4311 70-4314 70-4324 70-4325

Why it was recalled

Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.

Root cause (FDA determination)

Device Design

Action the firm took

The firm has issued a Customer Safety Advisory Notice dated 12/6/2006, to all sites that have the pre-R2.0 OPTIVUE Flat Panel Positioners installed. Users will have a new microswitch-based collision detection system, installed free of charge.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution- USA including MA, ME, NJ, NY, PA, MD, WV, NC, SC, GA, FL, AL, TN, KY, OH, IN, MI, IA, WI, SD, ND, MT, IL, NE, LA, OK, TX, WY, NV, CA, AK AND AR, and countries of Serbia, Australia, Austria, Belgium, Canada, Denmark, El Salvador, France, Germany, Hungary, India, Ireland, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, China, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, Ukraine, UK.

Timeline

Recall initiated: 2007-03-23
Posted by FDA: 2007-12-01
Terminated: 2011-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66449. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.