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
Reported: September 23, 2020 Initiated: August 7, 2020 #Z-2957-2020
Product Description
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
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
Details
- Recalling Firm
- Maquet Cardiovascular Us Sales, Llc
- Units Affected
- 105 total: US: 11 each OUS: 94 each
- 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.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Maquet Cardiovascular Us Sales, Llc. Units affected: 105 total: US: 11 each OUS: 94 each.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2020. Severity: Low. Recall number: Z-2957-2020.
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