Draeger Medical Systems, Inc. recalls Infinity Acute Care System (IACS) Monitoring System, Infinit
See all recalls from Draeger Medical Systems, Inc. →Recalled Product
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Model Number: MS20407. UDI-DI: 04049098054447. Rev 20, 21, and 23
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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