Reported Apr 15, 2020 · Terminated

ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with…

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

  • ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Lot codes and dates
    • Serial Numbers 3905
    • 70-4077
    • 4082
    • 70-4283
    • 70-4368
    • 5177
    • 3922
    • 5120
    • 5170
    • 5179
    • 5205
    • 5226
    • 5245
    • 5282
    • 5300
    • 5343
    • 5385
    • 5391
    • 5506
    • 5665
    • 4078
    • 70-4143
    • 70-4235
    • 70-4296
    • 70-4344
    • 5154
    • 5281
    • 5417
    • 3755
    • 3761
    • 3802
    • 3801
    • 3901
    • 3981
    • 4072
    • 70-4174
    • 70-4354
    • 70-4378
    • 5087
    • 5088
    • 5096
    • 5095
    • 5098
    • 5118
    • 5148
    • 5396
    • 5157
    • 5821
Amount recalled
1012

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 9, 2021 · Data as of Sep 19, 4:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.