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Emblem mri s-icd pg
Official notice
9 Nov 2022
Last checked
9 Nov 2022
An official Health Canada notice concerns Emblem mri s-icd pg. A subset of Emblem S-ICDs was manufactured in September and has an incorrect date/timestamp which may cause an inaccurate display of battery capacity. The device's manufacturing date/timestamp is used by the programmer and latitude™ patient management system to calculate and display the battery capacity. The battery capacity value is intended to decrement in a linear manner over the device's implant life. For devices with an incorrect manufacturing date/timestamp, the initial battery capacity displayed after exiting storage mode is approximately 10%. This displayed battery capacity behavior does not affect the device's performance (i.e., ability to detect/treat arrythmias) or the actual battery longevity. Recall start date: October 3, 2022. Published 2022-11-09.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72171
Official notice
2022-11-09
The hazard
The hazard
A subset of Emblem S-ICDs was manufactured in September and has an incorrect date/timestamp which may cause an inaccurate display of battery capacity. The device's manufacturing date/timestamp is used by the programmer and latitude™ patient management system to calculate and display the battery capacity. The battery capacity value is intended to decrement in a linear manner over the device's implant life. For devices with an incorrect manufacturing date/timestamp, the initial battery capacity displayed after exiting storage mode is approximately 10%. This displayed battery capacity behavior does not affect the device's performance (i.e., ability to detect/treat arrythmias) or the actual battery longevity. Recall start date: October 3, 2022.
How to check if you're affected
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
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Boston Scientific, Emblem Mri S-icd Pg.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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