Cardiohelp-I
Brand(s)
Last updated
Summary
Product
Cardiohelp-I
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 catalog number |
|---|---|---|
| Cardiohelp-I | 90410131 90410130 | 70104.8012 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Maquet Cardiopulmonary Gmbh
Kehler Strasse 31, Rastatt, Germany, 76437
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75365
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