Draeger Medical Systems, Inc.: Device Recall

Recall #Z-2189-2024 · 05/13/2024

Class II: Risk

Recall Details

Recall Number
Z-2189-2024
Classification
Class II
Product Type
Device
Recalling Firm
Draeger Medical Systems, Inc.
Status
Ongoing
Date Initiated
05/13/2024
Location
Andover, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
34,102 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.

Product Description

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

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.

Other Recalls by Draeger Medical Systems, Inc.

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.