FDA recall Z-0472-2023

Siemens Medical Solutions USA, Inc · Class II · device

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.

Reason for recall

When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter

Distribution

US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.

Key facts

Status
Ongoing
Initiation date
2022-11-09
Report date
2022-12-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0472-2023