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Sensis vibe

Official notice

31 Jan 2022

Last checked

31 Jan 2022

Medium riskHealth Canada

An official Health Canada notice concerns Sensis vibe. Under certain sporadic circumstances the Sensis Vibe Hemo System with VD12A software the Co (cardiac output) measurement using the thermodilution method will temporarily no longer be possible. This happens without any obvious reason. When the issue appears on the Sensis Vibe Hemo system the syringe icon will no longer come up in the Co thermodilution dialog. Recall start date: Nov 29, 2021 Published 2022-01-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63873

Official notice

2022-01-31

The hazard

Under certain sporadic circumstances the Sensis Vibe Hemo System with VD12A software the Co (cardiac output) measurement using the thermodilution method will temporarily no longer be possible. This happens without any obvious reason. When the issue appears on the Sensis Vibe Hemo system the syringe icon will no longer come up in the Co thermodilution dialog. Recall start date: Nov 29, 2021

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63873

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Affected products

Product 1

Affected Products - Sensis Vibe, Lot or Serial Number - 103218, 103221, 103266, 103268, 103220, Model or catalog number - 11007641

Risk / hazard

Under certain sporadic circumstances the Sensis Vibe Hemo System with VD12A software the Co (cardiac output) measurement using the thermodilution method will temporarily no longer be possible. This happens without any obvious reason. When the issue appears on the Sensis Vibe Hemo system the syringe icon will no longer come up in the Co thermodilution dialog. Recall start date: Nov 29, 2021

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens, Sensis Vibe.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63873

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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