CLASS II Device recall · Reported 15 Apr 2020 · FDA Enforcement Report

Oncor Impression Plus #5857912 recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Oncor Impression Plus #5857912 with Digital Linac Systems Control Console, distributed in 35 states. The recall was initiated on 18 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled1012

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1679-2020
FDA event ID: 85161
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Feb 2020
FDA classified: 7 Apr 2020
Reported: 15 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

18 Feb 2020	Recall initiated by company
7 Apr 2020	Classified by FDA	+49 days
15 Apr 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming

Alabama California Delaware Florida Georgia Iowa Illinois Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina Nebraska New Jersey Nevada

Questions about this recall

Is Oncor Impression Plus #5857912 with Digital Linac Systems Control Console recalled?

Yes. Siemens Medical Solutions USA recalled Oncor Impression Plus #5857912 with Digital Linac Systems Control Console on 18 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1679-2020.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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