Agency classClass IIOur severity:High FDA (Devices)·Z-0472-2023·Announced 2022-12-21

Linear accelerator software addresses potential wrong-site treatment risk

Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall involving high-risk potential for wrong-site radiation delivery in cancer treatment. Although no illnesses or injuries have been reported and the hazard is theoretical, the potential for serious harm to patients justifies a High severity rating.

Plain-English summary

Siemens Medical Solutions USA, Inc. has recalled ARTISTE, ONCOR, and PRIMUS linear accelerator systems running syngo RT Therapist software version 4.3.1 MR3 (Material Number 8162815). These devices deliver X-ray photon and electron radiation for cancer treatment.

A software usability issue in the site fraction group selection interface may allow operators to accidentally select the wrong treatment site. If this error occurs, radiation could be delivered to the wrong isocenter (treatment location) in the patient's body.

Eight units of the affected software version were distributed across California, Iowa, Louisiana, Nebraska, Nevada, Ohio, and South Carolina. The affected serial numbers are: 10736, 10737, 10822, 10850, 10886, 10843, 10865, and 10025.

Facilities using affected units should contact Siemens Medical Solutions for guidance on mitigation steps. Operators should verify site selection before each treatment delivery to prevent wrong-site radiation exposure.

The recalled product

Product: ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiation Therapy Equipment
Hazard: wrong-site-treatment
radiation-delivery-error
user-interface-error
Affected units: 8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

UDI: N/A S/N: 10736
10737
10822
10850
10886
10843
10865
10025 Software version 4.3.1 MR3

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · Siemens Medical Solutions USA, Inc

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