Print version of this report

TGA Action ID	RC-2025-RN-00553-1
Type of Product	Medical Device
Product Name/Description	SPRINTER CART and SPRINTER CART XL with an INFUSION POLE Affected products: All
ARTG Number	212398
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	According to IEC 60601-1:2005+AMD1:2012+AMD2:2020, clause 9.4.2.3 ‘Instability from horizontal and vertical forces’, if an equipment overbalances when being pushed/ leaned on/ etc. with 15% of its weight, the medical electrical equipment shall be marked with a clearly legible warning, e.g., safety sign according to ISO 7010-P017. Starting April 21, 2021, MCP implemented a safety sign on newly produced INFUSION POLEs but did not correct INFUSION POLEs manufactured before this date. Therefore, all INFUSION POLEs manufactured before April 21, 2021, are affected by this problem. Given the limited traceability of INFUSION POLEs to SPRINTER CARTs, along with the distribution methods used for the INFUSION POLEs, all SPRINTER CARTs and SPRINTER CARTs XL are considered to be potentially impacted and within the scope of this product correction. The SPRINTER CARTs and SPRINTER CART XL may overbalance, which could damage the CARDIOHELP/ ROTAFLOW/ ROTAFLOW II or disconnect or damage the perfusion disposable and result in no or low blood flow to the patient.
Instructions for Customers/Users	- Customers are to examine their inventory immediately to determine if they have any affected product. - Patients should be monitored as appropriate according to the facility’s standard of care. - Report any adverse events potentially related to the affected products to a local Getinge representative. - A Getinge service representative, if not present, will affix ‘Pushing prohibited’ label to INFUSION POLE of SPRINTER CART/ SPRNTER CART XL. This action has been finalised on 8/5/2026.
Action Commencement Date	23/06/2025
Responsible Entity	Getinge Australia Pty Ltd
Contact Information	Quality.AUNZ@getinge.com - Getinge