Infinity M500 Cardiac Monitor Poses Electrical Shock Risk
Draeger recalls 34,102 Infinity M500 monitoring systems due to electrical safety noncompliance. The devices pose a potential risk of electrical shock, burns, and cardiac arrhythmia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for electrical safety noncompliance with potential for serious harm (electrical shock, cardiac arrhythmia). No illnesses or injuries have been reported. Classified as High per rubric: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Draeger Medical Systems, Inc. is recalling 34,102 units of the Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power (Model No. MS20407, Rev 20, 21, and 23). The recall affects devices distributed nationwide in the United States and internationally.
The device does not fully comply with electrical safety Type CF requirements specified in IEC 60601-1 and IEC 60601-2-34 standards. This noncompliance creates a potential risk of electrical shock to patients, operators, and healthcare personnel.
Exposure to electrical shock could result in burns and cardiac arrhythmia. Healthcare facilities and individuals using these monitors should discontinue use and contact Draeger Medical Systems, Inc. for corrected units or replacement.
The recalled product
- Product
- Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
- Manufacturer
- Draeger Medical Systems, Inc.
- Affected units
- 34,102
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: MS20407. UDI-DI: 04049098054447. Rev 20
- 21
- and 23
Distribution
Distributed nationwide across the United States.
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