[Recalled] Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console. — A loose ODU plug / Coaxial cable connection may result in fluctuating flow valu… | FDA 2019
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console. |
|---|---|
| Brand / manufacturer | Maquet Cardiovascular Us Sales, Llc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0678-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 December 2019 |
| EAN / barcode | 04037691258997 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Maquet Cardiovascular Us Sales, Llc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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