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Emblem s-icd and latitude programming systems

Official notice

25 Jul 2022

Last checked

25 Jul 2022

Medium riskHealth Canada

An official Health Canada notice concerns Emblem s-icd and latitude programming systems. In December 2020, Boston Scientific committed to developing a software enhancement that detects and alerts Healthcare Professionals (HCPs) if an Emblem S-Icd exhibits hydrogen-induced accelerated battery depletion. This enhanced software allows clinicians to identify Emblem S-Icds exhibiting hydrogen-induced accelerated battery depletion sooner. This enhanced software is now available, and sales professionals are upgrading the programmers. Recall start date: July 7, 2022 Published 2022-07-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64393

Official notice

2022-07-25

The hazard

In December 2020, Boston Scientific committed to developing a software enhancement that detects and alerts Healthcare Professionals (HCPs) if an Emblem S-Icd exhibits hydrogen-induced accelerated battery depletion. This enhanced software allows clinicians to identify Emblem S-Icds exhibiting hydrogen-induced accelerated battery depletion sooner. This enhanced software is now available, and sales professionals are upgrading the programmers. Recall start date: July 7, 2022

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

64393

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Affected products

Product 1

Affected products - Emblem S-Icd System, Lot or serial number - Not applicable., Model or catalog number - 3200

Product 2

Affected products - Latitude Programming System, Lot or serial number - Not applicable., Model or catalog number - 3300

Risk / hazard

In December 2020, Boston Scientific committed to developing a software enhancement that detects and alerts Healthcare Professionals (HCPs) if an Emblem S-Icd exhibits hydrogen-induced accelerated battery depletion. This enhanced software allows clinicians to identify Emblem S-Icds exhibiting hydrogen-induced accelerated battery depletion sooner. This enhanced software is now available, and sales professionals are upgrading the programmers. Recall start date: July 7, 2022

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: Boston Scientific, Emblem S-icd And Latitude Programming.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64393

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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