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Navicare patient safety; voalte patient safety

Official notice

2 Jun 2023

MediumHealth Canada

An official Health Canada notice concerns Navicare patient safety; voalte patient safety. Baxter Corporation is issuing an urgent medical device correction for the Voalte Patient Safety, previously branded as Navicare Patient Safety, software versions 3.9.200 through 4.0.401. Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. Recall start date: May 23, 2023 Published 2023-06-02.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73749

Official notice

2023-06-02

The hazard

Baxter Corporation is issuing an urgent medical device correction for the Voalte Patient Safety, previously branded as Navicare Patient Safety, software versions 3.9.200 through 4.0.401. Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. Recall start date: May 23, 2023

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

73749

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Affected products

Product 1

Affected products - Navicare Patient Safety; Voalte Patient Safety, Lot or serial number - Software v.3.9.200 to 4.0.401, Model or catalog number - Not applicable.

Risk / hazard

Baxter Corporation is issuing an urgent medical device correction for the Voalte Patient Safety, previously branded as Navicare Patient Safety, software versions 3.9.200 through 4.0.401. Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. Recall start date: May 23, 2023

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: Hill-rom, Navicare Patient Safety Voalte Patient Safety.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73749

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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