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 | More than 10 numbers, contact manufacturer. | 70104.8012 |
Issue
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force. Insufficient securement of the slide rails to the lateral aspects to Cardiohelp could provide an opportunity of both/either the transport guard and/or the emergency drive (with the holder) to detach from Cardiohelp. This issue is serial # specific.
Recall Start Date: August 29, 2023
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-74247
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