Recall Z-1954-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1954-2019
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 one FDA 510(k) clearance: K153244. Product: Cios care fusion system. 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

1 on FDA's record

K153244 — Cios FusionSiemens Medical Solutions USA, Inc.·cleared 2016-03-07

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 care fusion system

Reason for recall

DAP chamber may be missing an insulating foil

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