Siemens Medical Solutions USA, Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model Number 5863472
Products Sold
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
Siemens Medical Solutions USA, Inc is recalling Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle radiation therapy system, w due to Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AR, CA, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MT, NE, NV, NJ, NY, NC, ND, OH, OK, PA, SC, SD, TN, TX, WV, WI, WY
Page updated: Jan 10, 2026