XPER FLEX CARDIO PHYSIOMONITORING SYSTEM - MAIN UNIT (2017-11-14)

Starting date:
November 14, 2017
Posting date:
December 14, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-65414

Affected products

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM - MAIN UNIT

Reason

While in Full Disclosure (FD) playback, a user may inadvertently close the full disclosure control window using the Esc key function, instead of pressing the "x" icon in the upper right corner of this window. Use of the Esc key function will close the full disclosure control window, but full disclosure waveforms and numerics will remain on the display (i.e. the system will remain in full disclosure playback mode), preventing the display of real-time waveforms, numerics, and any visual alarms.

Affected products

XPER FLEX CARDIO PHYSIOMONITORING SYSTEM - MAIN UNIT

Lot or serial number

US1619002099
US1623002117
US1624002199

Model or catalog number

FC2020

Companies
Manufacturer
Invivo, a Div. of Philips Medical Systems
12151 Research Parkway
Orlando
32826
Florida
UNITED STATES