Health product recall

FETAL SPIRAL ELECTRODE

Last updated

Summary

Product
FETAL SPIRAL ELECTRODE
Issue
Medical devices - Electrical Defect
What to do

Contact the manufacturer if you require additional information
 

Affected products

Affected Products

Lot or serial number

Model or catalog number

FETAL SPIRAL ELECTRODE

Not applicable

9898 031 37631

Issue

Between September 2012 and September 2021, Philips continued to include a 2007 edition of the IFU with the fetal spiral electrode product. This previous edition did not include the following warning messages in the "warnings" section of the IFU: Reuse may cause degradation of physical or electrical properties, Do not reuse on another patient due to risk of cross-infection the current edition of the of the fetal spiral electrode instructions for use (IFU) is part number 453564380371, September 2012. The previous edition of the IFU is part number 453564065231, July 2007.

 

Recall start date: 2021-11-01

Additional information

Details
Original published date: 2021-11-19
Alert / recall type
Health product recall
Category
Health product - Medical device - Obstetrics and gynaecology
Companies

PHILIPS ELECTRONICS LTD.

5th floor - 1875 BUCKHORN GATE, MISSISSAUGA

ON, CANADA

L4W 5P1

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63618