Class 2 Device Recall Infinity Acute Care System (IACS)

• Date Initiated by Firm: May 13, 2024
• Date Posted: June 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2189-2024
• Recall Event ID: 94644
• 510(K)Number: K203088
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
• Code Information: Model Number: MS20407. UDI-DI: 04049098054447. Rev 20, 21, and 23
• Recalling Firm/ Manufacturer: Draeger Medical Systems, Inc.; 6 Tech Dr; Andover MA 01810-2434
• For Additional Information Contact: Mike Kelhart; 267-664-1131
• Manufacturer 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.
• FDA Determined 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 Drager Service Technical Support between the hours of 8:00 AM - 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 1). If you have any questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM -4:30 PM EST at 267-664-1131 or via email at mike.kelhart@draeger.com.
• Quantity in Commerce: 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, 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MHX