CLASS II Device recall · Reported 4 Mar 2020 · FDA Enforcement Report

Coherence Oncologist recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Coherence Oncologist, distributed in 16 states. The recall was initiated on 16 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware versions 2.0.49, 2.0.50, 2.0.51

Quantity recalled64 Worldwide/26 Domestic

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-1346-2020
FDA event ID: 84795
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 16 Jan 2020
FDA classified: 21 Feb 2020
Reported: 4 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

16 Jan 2020	Recall initiated by company
21 Feb 2020	Classified by FDA	+36 days
4 Mar 2020	Published in enforcement report	+12 days

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

Reason for recall

A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could lead to incorrect repositioning of the patient and dose to wrong location.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

COHERENCE Oncologist, Model Nos. 07333680 & 07351898

Where it was distributed

Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.

California Florida Georgia Iowa Massachusetts Michigan Nebraska New Jersey Nevada New York Ohio Oklahoma Pennsylvania South Dakota Tennessee West Virginia

Questions about this recall

Is Coherence Oncologist recalled?

Yes. Siemens Medical Solutions USA recalled Coherence Oncologist on 16 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1346-2020.

Why was it recalled?

Which lots are affected?

Software versions 2.0.49, 2.0.50, 2.0.51

Where was it sold?

Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.

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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