Z-1954-2019Class II

Cios care fusion system

Name: Z-1954-2019 Cios care fusion system
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-06-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-06-20 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Cios care fusion system on 2019-06-20. FDA classified it as Class II and gives the reason as "DAP chamber may be missing an insulating foil". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1954-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-20
Posted: 2019-07-09
Terminated: 2020-04-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Cios care fusion system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: DAP chamber may be missing an insulating foil
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 1. Siemens will inspect the DAP chamber on your unit, and if necessary, replace it with insulated DAP chamber. 2. Siemens service organization will contact you shortly to arrange a date to perform this corrective action. 3. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
Quantity in commerce: 1
Distribution: IL, NE
Product codes and lots: material # 10308192 Serial # 31375

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1954-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1953-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-17	2019-07-09
Z-1954-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-17	2019-07-09

Product code OWB

K153244Class IICios FusionSiemens Medical Solutions USA, Inc. / cleared 2016-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)