Philips Electronics North America Corporation: Medical Device Recall in 2016 - (Recall #: Z-0858-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)

Product Classification:

Class II

Date Initiated: November 25, 2015

Date Posted: March 2, 2016

Recall Number: Z-0858-2016

Event ID: 72720

Reason for Recall:

Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.

Status: Terminated

Product Quantity: 1880 units

Code Information:

Software Versions: B.0.X

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated