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Cardiohelp-i
Official notice
8 Apr 2024
Last checked
8 Apr 2024
An official Health Canada notice concerns Cardiohelp-i. During service measurements on the Cardiohelp-I devices in the field, it was noticed that the measured patient leakage current exceeded the limit values of 50 μa specified in standard EN 60601-1:2006 + a1:2013. Patient leakage currents of up to 1337 μa were measured. Investigations have shown that only Cardiohelp-I devices with installed sensor panels (701051308) with an old sensor bridge (701049193) hardware version are affected. The new hardware version is not affected. Recall Start Date: March 18, 2024 Published 2024-04-08.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75365
Official notice
2024-04-08
The hazard
The hazard
During service measurements on the Cardiohelp-I devices in the field, it was noticed that the measured patient leakage current exceeded the limit values of 50 μa specified in standard EN 60601-1:2006 + a1:2013. Patient leakage currents of up to 1337 μa were measured. Investigations have shown that only Cardiohelp-I devices with installed sensor panels (701051308) with an old sensor bridge (701049193) hardware version are affected. The new hardware version is not affected. Recall Start Date: March 18, 2024
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: Maquet Cardiopulmonary, Cardiohelp-i.
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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