Recall Z-2189-2024 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draeger Medical Systems, Inc.
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
| Date | Jun 25, 2024 (initiated May 13, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | On May 13, 2024, the firm began notifying affected customers of the recall through letters titled "Urgent - Medical Device Correction". Customers were informed of the issue and given additional precautions to inspect the patient cables and probes, and to discard damaged or compromised accessories. Customers will be contacted by their local Draeger Service representative to arrange for modification of the affected M500 units to be carried out free of charge as soon as the material for modification is available. If you have any questions regarding the operation of the Product, please contact |
| Quantity | 34,102 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203088 | Infinity Acute Care System (IACS) Monitoring System Draeger Medical Systems, Inc., Feb 1, 2022 |