Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:16980
Brand Name:GE CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE
Model:Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE
Affected:
Software version:
Recalling Organisation:GE Healthcare Limited
Level 7, Vero Centre
48 Shortland St
Auckland 1010
Contact Information:0800 659 465
Manufacturer:GE Healthcare Finland Oy
Issue:Displayed Et-/Fi O2 values may be incorrect. A random deviation from the allowed tolerance limits of an O2 sensor component in the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units could cause up to 50% measurement error in Et-/Fi O2 values. An incorrect Et- /Fi O2 value could lead to a potential hypoxic situation or impaired clinical decision making.
Recall action type:Correction
Recall action:Product to be modified
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:11/7/2014
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