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SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip
SonarMed Inc. is recalling the SonarMed Airway monitoring system because of a software issue resulting in failure to detect a partial obstruction within 2.5 mm sensors and extending up to 3mm distal to the sensor tip.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Questions?
If you have questions about this recall, contact Medtronic Representative or Customer Service at 800-962-9888, Option 2.
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