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Philips Electronics North America Corporation recalls Philips Healthcare IntelliVue Info Center iX, A.0 866023
Recalled March 2, 2016 · FDA recall Z-0856-2016 · Philips Electronics North America
Hazard
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. · FDA Class II
Units
5671 units
Sold at
Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.
Description
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Product
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Manufacturer(s)
Philips Electronics North America Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →