Company: GE Healthcare
Date of Enforcement Report:7/30/2014
Class I:

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. Recall Number Z-2068-2014

REASON
Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et/Fi CO2 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/MANUFACTURER
GE Healthcare, Waukesha, WI on 6/112014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
2,948 (761 units US, 2,187 units OUS)

DISTRIBUTION
Nationwide and Internationally

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