Draeger Infinity Acute Care System Recall for Alarm Failure
Draeger Medical Systems is recalling 439 Infinity Acute Care System units because a high-grade SpO2 alarm may fail to activate after a medium-grade alarm is paused.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a failure of a life-threatening alarm system in a medical device, which aligns with the rubric criterion for 'Severe' (FDA Class II with significant injury/property-damage reports or high-risk structural defects).
Plain-English summary
Draeger Medical Systems, Inc. is recalling 439 units of the Draeger Infinity Acute Care System Monitoring Solution. The recall involves units with software versions VG2.0.3 and higher. These devices were distributed in the United States, specifically in the states of Massachusetts, New Hampshire, Indiana, California, Texas, New York, Oklahoma, and Illinois.
The recall was initiated after a test revealed that a high-grade, life-threatening SpO2 alarm (red) did not activate when SpO2 values decreased to the red alarm limit. This failure occurred after a low SpO2 (yellow) medium-grade alarm had been initiated in neonatal mode and subsequently paused. The failure to activate the high-grade alarm poses a risk of delayed clinical response to critical patient conditions.
Healthcare facilities and consumers who possess these devices should contact Draeger Medical Systems, Inc. for instructions on how to resolve the issue. The source text does not specify a particular action such as returning the device or applying a software patch, so users should follow the specific guidance provided by the manufacturer.
The recalled product
- Product
- Draeger Infinity Acute Care System Monitoring Solution
- Manufacturer
- Draeger Medical Systems, Inc.
- Affected units
- 439
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 (1)
- with software versions VG2.0.3 and higher.
Distribution
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