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IntelliVue Patient Monitor Systems and Multi-Measurement module (2016-01-04)
- Starting date:
- January 4, 2016
- Posting date:
- January 22, 2016
- 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-56750
Affected Products
- INTELLIVUE MP50 PATIENT MONITOR SYSTEM-MULTI MEASUREMENT SERVER
- INTELLIVUE X2 MULTI-MEASUREMENT MODULE-MAIN UNIT
- INTELLIVUE MP30 PATIENT MONITOR SYSTEM-MULTI MEASUREMENT SERVER
Reason
Philips has become aware that the hexad 12-Lead ECG monitoring derivation uses a 6-lead set and derives remaining leads to provide a non-diagnostic 12-Lead view, including ECG waves and ST measurements. The ST elevation alarm on the patient monitor or stand-alone X2 measurement module will not sound when indicated for all chest leads derived using hexad 12-Lead ECG monitoring in the host monitor configuration below: ST analysis: "off" STE: "on" STE alarms: "on"
Affected products
A. INTELLIVUE MP50 PATIENT MONITOR SYSTEM-MULTI MEASUREMENT SERVER
Lot or serial number
ALL
Model or catalog number
M3001A
Companies
- Manufacturer
- Philips Medizin Systeme Boeblingen GMBH
B. INTELLIVUE X2 MULTI-MEASUREMENT MODULE-MAIN UNIT
Lot or serial number
ALL
Model or catalog number
M3002A
Companies
- Manufacturer
- Philips Medizin Systeme Boeblingen GMBH
C. INTELLIVUE MP30 PATIENT MONITOR SYSTEM-MULTI MEASUREMENT SERVER
Lot or serial number
ALL
Model or catalog number
M3001A
Companies
- Manufacturer
- Philips Medizin Systeme Boeblingen GMBH