Recall Z-2189-2024— Draeger Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Draeger Medical Systems, Inc., initiated 2024-05-13. It names one FDA 510(k) clearance: K203088. Product: Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23. Reason: 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..
- Recalling firm
- Draeger Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-13
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.