Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Reported: December 18, 2019 Initiated: December 3, 2019 #Z-0678-2020
Product Description
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Reason for Recall
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Details
- Recalling Firm
- Maquet Cardiovascular Us Sales, Llc
- Units Affected
- 11 distributed in the US
- Distribution
- The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 11 distributed in the US.
Why was this product recalled? ▼
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0678-2020.
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