Recall Z-1679-2020— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1679-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-18

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-02-18, terminated 2021-02-09. It names 2 FDA 510(k) clearances: K982513, K882729. Product: ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13. Reason: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-02-18
Terminated: 2021-02-09
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K982513 — MX MEVATRONSiemens Medical Solutions USA, Inc.·cleared 1998-07-31
K882729 — MEVATRON, M 2 CLASSSiemens Medical Laboratories, Inc.·cleared 1988-09-19

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

ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Reason for recall

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

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