Siemens Medical Solutions USA, Inc ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857920, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857920, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
MODEL NUMBER: 5857920 : Serial Numbers: 3878, 4021, 4078, 70-4143, 70-4207, 70-4235, 70-4257, 70-4344, 70-4296, 3974, 70-4165, 70-4167, 3729, 5022, 5035, 5074, 3811, 3845, 3962, 3973, 70-4152, 5015, 70-4238, 70-4374, 70-4386, 5024, 704083, 3894, 4048, 70-4276, 70-4277, 70-4281, 3883, 70-4083.
Products Sold
MODEL NUMBER: 5857920 : Serial Numbers: 3878, 4021, 4078, 70-4143, 70-4207, 70-4235, 70-4257, 70-4344, 70-4296, 3974, 70-4165, 70-4167, 3729, 5022, 5035, 5074, 3811, 3845, 3962, 3973, 70-4152, 5015, 70-4238, 70-4374, 70-4386, 5024, 704083, 3894, 4048, 70-4276, 70-4277, 70-4281, 3883, 70-4083.
Siemens Medical Solutions USA, Inc is recalling ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerato due to Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode."
Recommended Action
Per FDA guidance
Distribution of Update Instructions TH007/07/S was sent to all affected sites on March 26, 2007. This was intended to inform users that Service Mode is only for use by authorized personnel, and that unauthorized and/or incorrect softpot parameter changes performed in Service Mode can result in the risk of patient mistreatment. Current control system software versions do not allow unplanned Dosimetry calibration data sets to be erroneously copied during "Service Mode."
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, AZ, AR, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WI, WY, DC, PR
Page updated: Jan 10, 2026