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Open, Classified

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

FDA Recall Z-2189-2024 · Posted 2024-06-25

Recalling FirmDraeger Medical Systems, Inc.
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2024-05-13
Product Quantity34,102 units

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.

Firm 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 [email protected].

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc. · 2022-02-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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