GE Healthcare Recalls DateX-Ohmeda S/5 Airway Modules Due to CO2 Measurement Failure
GE Healthcare is recalling DateX-Ohmeda S/5 Single-Width Airway Modules and E-miniC accessories because a CO2 detector failure may cause incorrect low readings, potentially impairing clinical decision-making for ventilated patients.
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 agency classified this as a Class I recall, which mandates a minimum severity score of 4 per the rubric, as the defect poses a significant risk of serious injury or death through impaired clinical decision-making.
Plain-English summary
GE Healthcare, LLC is recalling the DateX-Ohmeda S/5 Single-Width Airway Module, E-miniC, and related accessories, including specific software and modules. The recall involves 2,948 units distributed worldwide, including 761 units in the United States and 2,187 units in other countries.
The recall is due to a failure of the CO2 detector in the Single-Width Airway and Extension modules. This failure may cause a slow, continuous decrease in measured Et-/FiCO2 values. Incorrectly low CO2 values may impair clinical decision-making for both mechanically and spontaneously ventilated patients.
The affected products are indicated for monitoring CO2 and respiration rate of all hospital patients. Healthcare facilities should check their inventory against the provided serial numbers and contact GE Healthcare for further instructions on corrective actions.
The recalled product
- Product
- DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
- Manufacturer
- GE Healthcare, LLC
Distribution
Distributed nationwide across the United States.
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