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Avalon Fetal Monitors
- Starting date:
- December 18, 2009
- Posting date:
- January 18, 2010
- 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-26845
Recalled Products
- Avalon Fetal Monitor FM30 - Main Unit
- Avalon Fetal Monitor FM20 - Main Unit
- Avalon Fetal Monitor FM40
- Avalon Fetal Monitor FM50
Reason
Philips has received a number of complaints of inaccurate ultrasound-derived fetal heart rate readings from users of the Philips Avalon Fetal Monitors (models FM20, FM30, FM40 and FM50). Although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate monitoring, the frequency of such complaints is greater for these devices than for the previous-generation Philips series 50 fetal monitors. Clinical decisions based on unrecognized inaccuracies in fetal heart traces may lead health care professionals to perform unnecessary interventions such as caesarean delivery, fail to identify the need for interventions, or fail to identify fetal distress.
Affected products
A. Avalon Fetal Monitor FM30 - Main Unit
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
M2703A
Companies
- Manufacturer
-
Philips Medizin Systeme Boeblingen GMBH
B. Avalon Fetal Monitor FM20 - Main Unit
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M2702A
Companies
- Manufacturer
-
Philips Medizin Systeme Boeblingen GMBH
C. Avalon Fetal Monitor FM40
Lot or serial number
DE81001152
Model or catalog number
M2704A
Companies
- Manufacturer
-
Philips Medizin Systeme Boeblingen GMBH
D. Avalon Fetal Monitor FM50
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
M2705A
Companies
- Manufacturer
-
Philips Medizin Systeme Boeblingen GMBH