Recall Z-1953-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1953-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-20

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-06-20, terminated 2020-04-17. It names 2 FDA 510(k) clearances: K181560, K132094. Product: Cios Alpha VA20/ VA30 mobile X-Ray systems. Reason: DAP chamber may be missing an insulating foil.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-06-20
Terminated: 2020-04-17
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K181560 — Cios AlphaSiemens Medical Systems USA, Inc.·cleared 2018-10-24
K132094 — CIOS ALPHASiemens Medi Cal Solutions, Inc.·cleared 2014-03-11

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

Cios Alpha VA20/ VA30 mobile X-Ray systems

Reason for recall

DAP chamber may be missing an insulating foil

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