LifeDop 150/250/350 System - Probes (2017-10-06)

Starting date:

October 6, 2017

Posting date:

October 27, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-64956

• 
  Reason
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  Affected products

Affected products

1. LifeDop 150 System - Probes
2. LifeDop 250 System - Probes
3. LifeDop 350 System - Probes

Reason

The CooperSurgical 2 MHz Waterproof OB Probe is for obstetrical use in the labor and delivery department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability. CooperSurgical quality assurance program identified that the 2 MHz is incorrectly labeled with the 3 MHz probe label on September 19, 2017. The event was discovered internally during product complaint investigation.

Affected products