RecallRadar

FDA Device recall Z-1954-2019

Cios care fusion system

On 2019-07-17 the FDA classified a Class II recall of Cios care fusion system by Siemens Medical Solutions Usa, citing DAP chamber may be missing an insulating foil.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1954-2019
ClassificationClass II
Statusterminated
Initiated2019-06-20
Published2019-07-17
Last updated2026-09-13 11:55 UTC
CompanySiemens Medical Solutions Usa
DistributionIL, NE

Product

Cios care fusion system

Reason

DAP chamber may be missing an insulating foil

Identifiers

code_infomaterial # 10308192 Serial # 31375

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1954-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.