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

FDA device recall Z-2189-2024 · posted 2024-06-25 · Open, Classified

Recall details

Recalling firm

Draeger Medical Systems, Inc.

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.

Action taken

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 mike.kelhart@draeger.com.

Root cause

Device Design

Status

Open, Classified

Product code

MHX

Quantity 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, Ch

Date initiated

2024-05-13

Date posted

2024-06-25

Location

Andover, MA

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