The Recall Desk
HighFDA (Devices)·Z-1954-2019·Announced 2019-07-17

Siemens Cios Care Fusion System Recalled for Missing Insulating Foil

Siemens Medical Solutions is recalling one Cios Care Fusion System unit because the DAP chamber may be missing an insulating foil.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling one unit of the Cios Care Fusion System. The recall is due to a potential defect where the DAP chamber may be missing an insulating foil.

The affected unit is identified by material number 10308192 and serial number 31375. The product was distributed in Illinois and Nebraska.

This recall is classified as Class II by the FDA. Consumers and healthcare facilities should contact Siemens Medical Solutions for further instructions regarding the affected equipment.

The recalled product

Product
Cios care fusion system
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • material # 10308192 Serial # 31375

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Siemens Medical Solutions USA, Inc

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