FDAFDA · Food and drugs·Recall number Z-0856-2016
Philips Healthcare IntelliVue Info Center iX, A.0 866023
Published March 2, 2016 · Recall initiated: November 25, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Electronics North America Corporation
- Distributor
- 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.
- Lot
- Software A.0.X
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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