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