Siemens Medical Solutions USA, Inc: ONCOR IMPRESSION Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857912, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

Recall number

Z-0166-2008

Recalling firm

Siemens Medical Solutions USA, Inc

Product

ONCOR IMPRESSION Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857912, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

Status

Terminated

Initiated

2007-03-22

Posted

2007-11-09

Terminated

2010-12-18

Reason

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."

Root cause

Software design

Action

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."

Quantity

188 units

Distribution

Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and FOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uzbekistan, Venezuela, Vietnam, and Zambia

Lot, serial or model codes

MODEL NUMBER: 5857912: Serial Numbers: 3753, 3754, 3755, 3761, 3764, 3769, 3778, 3783, 3791, 3793, 3801, 3802, 3803, 3804, 3815, 3846, 3855, 3877, 3888, 3901, 3907, 3945, 3948, 3953, 3955, 3957, 3964, 3975, 3981, 3989, 3998, 4015, 4019, 4035, 4065, 4067, 4072, 4091, 5033, 5060, 5088, 5093, 5096, 70-4119, 70-4122, 70-4129, 70-4135, 70-4142, 70-4144, 70-4145, 70-4157, 70-4159, 70-4161, 70-4166, 70-4172, 70-4174, 70-4175, 70-4177, 70-4183, 70-4222, 70-4262, 70-4306, 70-4317, 70-4343, 70-4345, 70-4349, 70-4354, 70-4356, 70-4362, 70-4378, 70-4379, 3956, 4011, 70-4136, 70-4154, 70-4334, 4024, 3796, 3799, 3865,  70-4361, 3795, 4074, 5002, 5034, 5057, 3739, 3808, 4017, 4022, 4068, 4081, 4084, 4096, 5001, 5011, 5032, 5053, 5058, 5086, 5087, 5095, 70-4107, 70-4132, 70-4147, 70-4149, 70-4153, 70-4171, 70-4189, 70-4288, 70-4312, 70-4331, 70-4333, 70-4366, 5031, 70-4158, 3983, 3823, 3965, 5061, 5091, 70-4124, 70-4137, 70-4329, 70-4348, 5068, 5085, 70-4215, 70-4253, 70-4272, 70-4305, 70-4335, 70-4338, 70-4123, 70-4176, 70-4209, 3816, 4012, 4053, 5023, 70-4186, 70-4241, 70-4244, 3776, 3848, 3858, 3963, 4002, 4027, 70-4097, 70-4346, 70-4384, 4071, 3836, 3827, 4005, 5039, 5040, 70-4231, 5030, 70-4328, 70-4365, 4026, 70-4258, 70-4301, 4009, 3916, 70-4278, 3925, 3954, 5027, 5044, 5069, 70-4224, 70-4295, 70-4299, 5004, 704093, 3968, 4037, 70-4193, 70-4292, 70-4127, 3841, 3863, 4008, 4062, 4064.

510(k) numbers

["K993425"]

PMA numbers

not on file

Product code

IYE

Firm FEI

2937457

Firm city

Concord

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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