Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Reported: March 2, 2016 Initiated: November 25, 2015 #Z-0858-2016
Product Description
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Reason for Recall
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Details
- Recalling Firm
- Philips Electronics North America Corporation
- Units Affected
- 1880 units
- Distribution
- 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.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm). Recalled by Philips Electronics North America Corporation. Units affected: 1880 units.
Why was this product recalled? ▼
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0858-2016.
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