Dear Customer,
Dear sales partners,
We would like to inform you today about the latest safety information from Stryker for HeartSine and Omron devices. For details, please refer to the Original message of the manufacturer.
"As MedX5 is a company certified according to ISO 13485, ISO 9001 and ISO 14001 and has set its own quality standards in addition to various manufacturer specifications, we confirm that your defibrillator(s) have been checked for completeness and functionality before shipping.
Regardless of whether you are an end customer or a sales partner, all defibrillators and other medical products are shipped ready for use with the PAD-PAK battery and electrode cassette inserted, checked language, correct instructions for use, etc. As a general rule, no unchecked devices leave our warehouse!
Immediately after receiving the safety information, we were able to confirm to the manufacturer that the defibrillators supplied by MedX5 work perfectly. If you still have doubts, switch on your defibrillator once and listen to the voice message. Please check the expiration date of the PAD-PAK beforehand (it should not have expired).
Safety is our top priority. We therefore ask you to continue to purchase accessories from us and to have us carry out safety checks (STK), because only then can we advise you comprehensively and reliably inform you about the necessary measures!"
If you have any questions, please feel free to contact us!
Your MedX5 Team
Updated 02.05.2024: Report from BfArM
