Product description
(Battery charger for the Precision Spinal Cord Stimulator System). Models SC-5300 and ONS-5564. ARTG number 128680
See a list of details to help identify the product
Reason the product is recalled
Patient reports of second and third degree burns in the area of charging.
The hazards to consumers
Illness or mistreatment (Class II)
What consumers should do
Patients will be contacted directly by their physician.
Details to help identify the product
Supplier running the recall
Boston Scientific Pty Ltd
Where the product was sold
Australian Capital Territory
New South Wales
Victoria
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2008/10343 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.