Health product recall

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

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

ShockPulse Transducer

Lot or serial number

1910PW30607604

1910PW30607811

Model or catalog number

SPL-T

Companies
Manufacturer

Gyrus ACMI, Inc.

136 Turnpike Road

Southborough

01772

Massachusetts

UNITED STATES