Health product recall

RotaFlow Console

Last updated

Summary

Product
RotaFlow Console
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

RotaFlow Console

More than 10 numbers, contact manufacturer.

70104.3292

Issue

During internal validation of new replacement batteries, MCP identified an issue on the RotaFlow console. This issue can cause the device to stop battery charging after the battery operation mode has been utilized. Further investigation identified a software problem as root cause. Because of this, all devices on the market are considered affected by this issue.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Maquet Cardiopulmonary Gmbh
Kehler Strasse 31, Rastatt, Germany, 76437
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82878

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