FDAMay 13, 2024device

Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.

What to do

FDA enforcement status: Ongoing

Brands named

draeger medical systemsdraegerdraeger medical

UPCs

04049098054447

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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