Embryology Heated Plate within RI Witness (2019-09-10)

Starting date:

September 10, 2019

Posting date:

October 25, 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-71353

Last updated: 2019-10-25

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  Reason
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  Affected products

Affected Products

Embryology Heated Plate within RI Witness

Reason

CooperSurgical became aware from complaint investigations that there is a risk that the touchpad may not work properly after cleaning of the Embryology Heated Plate within the RI Witness. The root cause has been identified to be liquid ingress into the keypad which has the potential to produce an electrical path across the tracks on the keypads' membrane tail. This failure mode does not affect the temperature controller, which continues to maintain proper temperature.

Affected products