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Cobalt and crome mri surescan

Official notice

3 Jun 2022

Last checked

3 Jun 2022

Medium riskHealth Canada

An official Health Canada notice concerns Cobalt and crome mri surescan. A software update for Carelink Smartsync™ device managers (Smartsync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDS), and Cardiac Resynchronization Therapy Defibrillators (CRT-DS). Recall start date: April 12, 2022 Published 2022-06-03.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64228

Official notice

2022-06-03

The hazard

A software update for Carelink Smartsync™ device managers (Smartsync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDS), and Cardiac Resynchronization Therapy Defibrillators (CRT-DS). Recall start date: April 12, 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

64228

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Affected products

Product 1

Affected products - Cobalt Vr Mri Surescan, Lot or serial number - RSF604533S RSF604560S RSF604562S, Model or catalog number - DVPB3D1 DVPB3D4

Product 2

Affected products - Cobalt Dr Mri Surescan, Lot or serial number - RSO606773S RSO606771S RSO606769S, Model or catalog number - DDPB3D4 DDPB3D1

Product 3

Affected products - Crome Dr Mri Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DDPC3D4 DDPC3D1

Product 4

Affected products - Carelink Smartsync Cobalt Crome Application, Lot or serial number - All lots., Model or catalog number - D00U005

Product 5

Affected products - Crome Hf Quad Crt-D Mri Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTPC2QQ DTPC2Q1

Product 6

Affected products - Cobalt Hf Crt-D Mri Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTPC2Q1 DTPB2D4

Product 7

Affected products - Crome Hf Crt-D Mri Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DTPC2D4 DTPC2D1

Product 8

Affected products - Crome Vr Mri Surescan, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - DVPC3D4 DVPC3D1

Risk / hazard

A software update for Carelink Smartsync™ device managers (Smartsync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDS), and Cardiac Resynchronization Therapy Defibrillators (CRT-DS). Recall start date: April 12, 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: Medtronic, Cobalt And Crome Mri Surescan.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64228

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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