FDA Device recall Z-0907-2013

SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS syste…

FDA Device
Class II
terminated
Published 2013-03-13

On 2013-03-13 the FDA classified a Class II recall of SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS syste… by Siemens Medical Solutions Usa, citing siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previousl….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0907-2013
Classification	Class II
Status	terminated
Initiated	2013-01-17
Published	2013-03-13
Last updated	2026-09-13 11:53 UTC
Company	Siemens Medical Solutions Usa
Distribution	n/a

Product

SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.

Reason

Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console, thus repeating the already delivered Monitor Units of the same beam or segment.

Identifiers

code_info	All codes/units of ARTISTE model.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0907-2013%22

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