Recall – Cardio Physiomonitoring System Software Issues

Company: Philips Electronics North America Corporation
Date of Enforcement Report: 12/14/2018
Class II

PRODUCT

Xper Flex Cardio Physiomonitoring System

  • Software versions 1.5.16.0322 and 1.6.1.0390,
  • Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081

Recall Number: Z-0614-2019

REASON

There are 3 issues:

  • Under certain conditions, real time waveforms may not be accurately plotted or displayed.
  • The oxygen saturation (SpO2) numeric value displayed on the device may freeze.
  • In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update

RECALLING FIRM/MANUFACTURER

Philips Electronics North America Corporation, Andover, MA on 11/15/2018. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
651 units

DISTRIBUTION
U.S. Nationwide and International

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.