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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

  1. Avalon Fetal Monitor FM30 - Main Unit
  2. Avalon Fetal Monitor FM20 - Main Unit
  3. Avalon Fetal Monitor FM40
  4. 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