Oxygen Sensors in Incubators May Display Inaccurate Readings
CooperSurgical oxygen sensors in incubators may display inaccurate oxygen readings that do not trigger alarms when discrepancies occur. This could result in loss of embryos during storage.
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: This is a FDA Class II medical device with a functional defect that may result in loss of embryos during storage. Although no actual injuries or illnesses have been reported, the potential harm from inaccurate oxygen readings in critical storage equipment constitutes a risk-of-harm scenario. The lack of alarm functionality compounds the risk.
Plain-English summary
CooperSurgical, Inc. has recalled oxygen sensors (Model K54019-2) used in G185 and G210 incubators and G603 work chambers. A total of 421 units with identified serial numbers have been distributed to international locations.
The sensors display oxygen level readings that differ from measurements taken by external gas analyzers. When the sensor display shows 5%, external meters read between 3% and 12%. The affected incubators do not generate alarms when these discrepancies occur.
This malfunction may result in loss of embryos during storage. Customers with affected units should contact the manufacturer for instructions on replacement or repair.
The recalled product
- Product
- Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell…
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 421
Distribution
Distribution scope not specified by the agency.
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