Recall Z-0858-2016— Philips Electronics North America Corporation

Name: FDA recall Z-0858-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-25

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2015-11-25, terminated 2017-09-06. It names one FDA 510(k) clearance: K102495. Product: Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm). Reason: Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-11-25
Terminated: 2017-09-06
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K102495 — M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0Philips Medical Systems·cleared 2010-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.