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XPER FLEX CARDIO PHYSIOMONITORING SYSTEM-MAIN UNIT (2017-11-17)
- Starting date:
- November 17, 2017
- Posting date:
- December 8, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65328
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
All lots
Model or catalog number
FC2020
Companies
- Manufacturer
-
Invivo, a Div. of Philips Medical Systems
12151 Research Parkway
Orlando
32826
Florida
UNITED STATES