CLASS II ONGOING Device recall · Reported 3 Jul 2024 · FDA Enforcement Report
Infinity Acute Care System (IACS) Monitoring System recalled
Draeger Medical Systems is recalling Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, distributed nationwide in the US. The recall was initiated on 13 May 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2189-2024
- FDA event ID
- 94644
- Recalling firm
- Draeger Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 May 2024
- FDA classified
- 25 Jun 2024
- Reported
- 3 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 13 May 2024 | Recall initiated by company | |
| 25 Jun 2024 | Classified by FDA | +43 days |
| 3 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 as listed by the FDA
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Where it was distributed
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.
Questions about this recall
Why was it 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 lots are affected?
Model Number: MS20407. UDI-DI: 04049098054447. Rev 20, 21, and 23
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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