Recall Z-2068-2014— GE Healthcare, LLC
Class I · Terminated
Class I FDA medical device recall by GE Healthcare, LLC, initiated 2014-06-11, terminated 2016-03-29. It names 2 FDA 510(k) clearances: K052582, K043276. 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.. Reason: Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low CO2 values..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-06-11
- Terminated
- 2016-03-29
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
2 on FDA's record- K052582 — DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
- K043276 — DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low CO2 values.
Data sourced from openFDA. This site is unofficial and independent of the FDA.