Home / Recalls / Draeger Medical Systems, Inc. / Z-2189-2024

Z-2189-2024 Class II Ongoing

Recalled by Draeger Medical Systems, Inc. — Andover, MA

Recall Details

Product Type
Devices
Report Date
July 3, 2024
Initiation Date
May 13, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34,102 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution. International distribution to Afghanistan, Argentina, Armenia, Australia, Austria, Belarus, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Egypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Liechtenstein, Lithuania, Malaysia, Malta, Martinique, Mexico, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Fed., San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.

Code Information

Model Number: MS20407. UDI-DI: 04049098054447. Rev 20, 21, and 23

Other recalls by Draeger Medical Systems, Inc.

  • Z-1066-2025 Class II — Infinity Central Station. Model Number: MS26800 The Infinity CentralStation ( (January 14, 2025)
  • Z-1992-2023 Class II — Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): R (May 16, 2023)
  • Z-1471-2023 Class II — Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatri (April 5, 2023)
  • Z-1472-2023 Class II — Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse o (April 5, 2023)
  • Z-1365-2022 Class II — Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. n (May 20, 2022)
  • Z-2047-2018 Class I — Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, cl (May 15, 2018)
  • Z-2046-2018 Class I — Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, c (May 15, 2018)
  • Z-1440-2014 Class I — Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part n (March 5, 2014)
  • Z-1298-2014 Class I — Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (E (February 7, 2014)
  • Z-0714-2014 Class II — Draeger Infinity Acute Care System Monitoring Solution (December 10, 2013)