Siemens Medical Solutions USA, Inc Siemens, Oncor Impression, Part No.: 58 57 920, 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 Impression, Part No.: 58 57 920, 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 5857920
Products Sold
Model number 5857920, Serial Numbers 3729 3345 3811 3845 3883 3973 3974 4021 4048 70-4083 70-4083 70-4143 70-4152 70-4165 70-4167 70-4207 70-4235 70-4257 70-4281 70-4296 70-4344
Siemens Medical Solutions USA, Inc is recalling Siemens, Oncor Impression, Part No.: 58 57 920, Medical Charge particle radiation therapy system,wit 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