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