ShockPulse Transducer (2020-05-06)

Starting date:

May 6, 2020

Posting date:

May 22, 2020

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-73153

Last updated: 2020-05-22

• Reason
• Affected products

Affected Products

ShockPulse Transducer

Reason

Gyrus ACMI, Inc. Initiated the recall as a component within the ShockPulse Transducer (SPL-T) contained non-conforming material that may lead to the transducer's loss of durability. Loss of durability could become evident in material warping following autoclave sterilization, potentially allowing fluid ingress into the transducer. Fluid ingress can result in device failure or electrical shock to user or patient.

Affected products