Reported Jul 30, 2014 · Terminated
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A…
GE Healthcare, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- 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.
- Lot codes and dates
- Serial # Model #6
3,258 of 3,258 codes
6837005E-MINIC-006838210E-MINIC-006845207E-MINIC-006845218E-MINIC-006845228E-MINIC-006845248E-MINIC-006860768E-MINIC-006860858E-MINIC-006876048E-MINIC-006876050E-MINIC-006876052E-MINIC-006876054E-MINIC-006878048E-MINIC-006888716E-MINIC-006888726E-MINIC-006888755E-MINIC-006889935E-MINIC-006889950E-MINIC-006891094E-MINIC-006891114E-MINIC-006891115E-MINIC-006891116E-MINIC-006891117E-MINIC-006891121E-MINIC-006891130E-MINIC-006891137E-MINIC-006891139E-MINIC-006892616E-MINIC-006892626E-MINIC-006827924E-MINIC-00
- Serial # Model #
- Amount recalled
- 2,948 (761 units US, 2,187 units OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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