Z-1038-2013Class II

SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for...

Name: Z-1038-2013 SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for...
Creator: Siemens Medical Solutions USA, Inc
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor.... FDA classified it as Class II and gives the reason as "Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing...". 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-1038-2013
Classification: Class II
Status: Terminated
Posted: 2013-04-02
Terminated: 2014-08-28
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE Impression TH, Part No. 7341410, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Siemens Medical Solutions sent a Customer Information letter via mail to all affected customers. The letter identified the affected product, problem and provide instructions on the correction. Customers were instructed to include the Customer Information letter in the Owner Manual chapter "Safety Advisory Letters". 9-16-13 UPDATE: - Control Console SW 9.2.18 was released to support the rol-out 10/18/2013; Distribution of update instructions for TH017/13S and TH018/13S - Distribtuion of the Control Console SW 9.2.18 released
Quantity in commerce: 621 units (foreign account) in total
Distribution: Worldwide Distribution
Product codes and lots: All units of these models.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1038-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1036-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1037-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1038-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1039-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1040-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1041-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1042-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1043-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1044-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01

Product code IYE

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)