Philips Electronics North America Corporation recalls Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)

Recalled March 2, 2016 · FDA recall Z-0857-2016 · 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

5569 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 PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)

Manufacturer(s)

Philips Electronics North America Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →