Recall Z-0441-2022— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0441-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-09

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2021-12-09, terminated 2023-05-04. It names one FDA 510(k) clearance: K142434. Product: ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815. Reason: Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2021-12-09
Terminated: 2023-05-04
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K142434 — ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1Siemens Medical Solutions USA, Inc.·cleared 2014-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815

Reason for recall

Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury

Data sourced from openFDA. This site is unofficial and independent of the FDA.