Z-1346-2020Class II

COHERENCE Oncologist, Model Nos. 07333680 & 07351898

Name: Z-1346-2020 COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-01-16
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-01-16 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of COHERENCE Oncologist, Model Nos. 07333680 & 07351898 on 2020-01-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1346-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-16
Posted: 2020-02-21
Terminated: 2021-01-04
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: COHERENCE Oncologist, Model Nos. 07333680 & 07351898
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: The firm started notifying customers on January 16, 2020, with letters titled Urgent Medical Device Correction. Customers were advised of the product safety issue. To avoid the possibility of an incorrect alignment of the patient, the user must ensure that filtered images arrive on the COHERENCE Oncologist, or apply any additional filters to the image BEFORE using the "interactive shift" or "landmark registration" tools. The firm will be offering a software solution for the issue free of charge. The firm's letter stated that based on their investigation, customers may continue to use their devices.
Quantity in commerce: 64 Worldwide/26 Domestic
Distribution: Domestic distribution to CA, FL, GA, IA, MA, MI, NE, NJ, NV, NY, OH, OK, PA, SD, TN, WV. Worldwide foreign distribution.
Product codes and lots: Software versions 2.0.49, 2.0.50, 2.0.51

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1346-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1346-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-21

Product code IYE

K060633Class IICoherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0Siemens Medical Solutions USA, Inc. / cleared 2006-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)