Maquet Cardiovascular Us Sales, Llc: 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

Is my product affected?

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

• UPC 04037691562445

Check against the official notice below — it lists the full affected range.

What happened

Maquet Cardiovascular US Sales, LLC has recalled the Instructions for Use (IFU) for the Maquet/Getinge Rotaflow System Console (115V/60Hz), a centrifugal pump system device. The IFU incorrectly references serial number 90437000 when it should state that the document applies to Rotaflow Consoles as of serial number 94175452, which are affected by implementation of the new IEC standard 60601-1-2, 4th edition. The affected devices have serial numbers 94175452 through 94175518 (specific numbers listed).

The recalled devices were distributed worldwide, including 11 units in the United States across multiple states (Maine, New York, Nevada, Ohio, Texas, Virginia, and Washington) and 94 units in other countries including China, Colombia, India, Italy, Mexico, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, and the United Kingdom. The source document does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition

Details from the source

Reason for recall: Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition Distribution: Worldwide distribution - US Nationwide distribution including in the states of ME, NY, NV, OH, TX, VA, WA and the countries of China, Colombia, India, Italy, Mexico, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arabic Emirates, United Kingdom. Quantity: 105 total: US: 11 each OUS: 94 each Lot/code info: Serial Numbers: 94175452 94175453 94175454 94175455 94175460 94175461 94175462 94175515 94175516 94175517 94175518 UDI: 04037691562445

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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