Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Reported: July 3, 2024 Initiated: May 13, 2024 #Z-2189-2024
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.
Details
- Recalling Firm
- Draeger Medical Systems, Inc.
- Units Affected
- 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.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23. Recalled by Draeger Medical Systems, Inc.. Units affected: 34,102 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2024. Severity: Moderate. Recall number: Z-2189-2024.
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