Maquet Rotaflow System Console Instructions for Use Recall
Maquet Cardiovascular is recalling Instructions for Use for the Rotaflow System Console because the documents reference an incorrect serial number.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation error regarding serial numbers, not a functional device defect.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling the Instructions for Use (IFU) for the Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz). The recall involves 105 units distributed worldwide, including 11 units in the United States and 94 units in other countries.
The recall is due to a documentation error where the IFU references an incorrect serial number (90437000). The document should state that it applies to ROTAFLOW Consoles as of serial number 94175452, which are affected by the implementation of the new IEC standard 60601 1 2, 4th edition.
Affected serial numbers include 94175452, 94175453, 94175454, 94175455, 94175460, 94175461, 94175462, 94175515, 94175516, 94175517, and 94175518. Users should verify their device serial numbers against this list and contact the manufacturer for corrected documentation.
The recalled product
- Product
- Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Category
- Medical Device — Cardiovascular
- Hazard
Distribution
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