Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22553
Brand Name: Ultrasound Transducer Norway TOE
Model: TEE probe models 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RS
Affected:
Software version:
Recalling Organisation:GE Healthcare Limited
Level 7, Vero Centre
48 Shortland St
Auckland 1010
Contact Information:0800 659 465
Manufacturer:GE Vingmed Ultrasound AS
Issue:The Tristel Trio Wipes System has been validated for efficacy and residual toxicity for TEE probes that do not have visible signs of wear or damage, and when used in connection with shorter procedure times such as cardiac scans.
Further testing has identified a need for clarification of previously communicated disinfection guidance for GE TEE Probes. Specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods may not always be effective when used in connection with procedures that have long TEE probe intubation times, such as cardiac surgeries, and/or with TEE probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:7/2/2018
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