Draeger Infinity Acute Care System Recall for Alarm Failure
Draeger Medical Systems is recalling Infinity Acute Care Systems (M540) because specific units may fail to display audio or visual alarms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a medical device where the failure to annunciate alarms poses a risk of harm to patients, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Draeger Medical Systems, Inc. is recalling the Infinity Acute Care System (M540), catalog numbers MK31501, MK31701, and MK31722. The recall affects 37 units in the United States and 682 units outside the United States. The affected units are distributed across five US states (AZ, NH, SD, TN, TX) and numerous foreign countries.
The recall is due to a defect in Cockpits with revision index 06 or higher that contain 4GB RAM modules. These specific units may not annunciate audio or visual alarms on the Cockpit and Central Station. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice. If a unit is affected, it should be removed from service and returned to Draeger Medical Systems for repair or replacement.
The recalled product
- Product
- Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
- Manufacturer
- Draegar Medical Systems, Inc.
- Hazard
Distribution
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