Health product recall

Single Patient Use Lead Set (2019-09-03)

Starting date:
September 3, 2019
Posting date:
October 3, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71131

Last updated: 2019-10-03

Affected Products

Single Patient Use Lead Set

Reason

The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. As a result, the receptacle in the trunk cable for the 5-lead chest lead set may be partially blocked, preventing or impeding the connection of all leads necessary to obtain a 12-lead ECG measurement.

Affected products

Single Patient Use Lead Set

Lot or serial number
  • 2019-03-18
  • 2019-05-18
  • 2019-06-18
Model or catalog number

9.89803E+11

Companies
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES