Fetal Scalp Electrode, Single Spiral (2019-01-29)
- Starting date:
- January 29, 2019
- Posting date:
- March 1, 2019
- 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-69180
Affected Products
Fetal Scalp Electrode, Single Spiral
Reason
During use of the Philips FSE it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery. Beginning in 2018, Philips has noted an increase in the number of reports of tip breakage received from customers.
Affected products
Fetal Scalp Electrode, Single Spiral
Lot or serial number
All lots.
Model or catalog number
9898 031 37631
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES