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XPER FLEX CARDIO PHYSIOMONITORING SYSTEM-MAIN UNIT (2015-10-22)
- Starting date:
- October 22, 2015
- 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-55762
Affected Products
XPER FLEX CARDIO PHYSIOMONITORING SYSTEM-MAIN UNIT
Reason
Philips has become aware that the SpO2 (peripheral capillary oxygen saturation) and non-invasive blood pressure (NIBP) waveform and numeric values displayed on the device may freeze, resulting in the display of measurements that are not current. Although SpO2 and NIBP monitoring and alarms are no longer functional, all other monitoring parameters are functional and visible. If this problem were to occur, the device can be reset by power cycling and the reset will allow the customer to continue monitoring. However, power cycling the device does not prevent the issue from recurring.
Affected products
XPER FLEX CARDIO PHYSIOMONITORING SYSTEM-MAIN UNIT
Lot or serial number
All lots
Model or catalog number
FC2010
Companies
- Manufacturer
-
Invivo, a Div. of Philips Medical Systems
12151 Research Parkway
Orlando
32826
Florida
UNITED STATES