Novalung Sensor Box Communication Failure May Disable Flow Measurement
The Novalung Sensor Box may experience communication failures between its flow sensor and sensor box component, potentially disabling flow measurement and air bubble detection. The recall affects 115 units distributed across 16 US states.
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 medical device recall with potential for serious patient harm (disabled flow measurement and air bubble detection on critical respiratory support equipment). No hospitalizations or injuries reported, making this a risk-of-harm scenario without confirmed injury, warranting 'High' severity.
Plain-English summary
Fresenius Medical Care Holdings, Inc. has recalled 115 units of the Novalung Sensor Box (model F30000163), a component of the Novalung Console system. The Novalung Sensor Box is a medical device intended for long-term respiratory and cardiopulmonary support in adult patients with acute respiratory or cardiopulmonary failure.
The device may experience communication failures between the flow sensor and the sensor box. When this occurs, error messages 206 (yellow) or 208 (red) appear, indicating a technical failure in flow measurement. An interrupted communication could disable flow measurement and air bubble detection, which are critical safety functions during use.
The affected 115 units are identified by specific serial numbers and were distributed nationwide in 16 states: Alabama, Arizona, California, Colorado, Florida, Illinois, Michigan, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, and West Virginia.
The recalled product
- Product
- Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blo
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- communication-failure
- flow-measurement-failure
- air-bubble-detection-failure
Distribution
Distributed nationwide across the United States.
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