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Infinity Acute Care System (IACS) Monitoring System… recallZ-2189-2024 · Draeger Medical Systems, Inc. · initiated May 13, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Draeger Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Device Design

What the company is doing

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 [email protected].

Recall details

Recall number
Z-2189-2024
Status
Open, Classified
Initiated by the company
May 13, 2024
Posted by the FDA
Jun 25, 2024
Recalling firm
Draeger Medical Systems, Inc.
Quantity
34,102 units
Product code
MHX
FDA submissions
K203088
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.

Product description

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

Code information (models, lots, serial numbers)

Model Number: MS20407. UDI-DI: 04049098054447. Rev 20, 21, and 23

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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