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الجمعة - جمادى الآخرة 26, 1446
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SA-23-12-24-720
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
PrisMax
الأجهزة المتأثرة
Software Version: 3.4 For the product Code and serial number, please refer to the attachment.
الممثل المعتمد
Baxter AG
سبب المشكلة
It has been identified an issue with the above software version that causes some displayed Effluent dose values to be different than what was actually delivered by the PrisMax system.
الإجراء التصحيحي
Please take the following actions: 1. Stop using your affected PrisMax devices with software v3.4. 2. Baxter is working on a protocol to revert the software on the devices from v3.4 back to v3.3. Once the downgrade is available, a local Baxter representative will contact your facility to determine the correction plan and schedule the downgrade for the impacted device(s). Manufacturer Action: Instructions and Correction.
المرفقات
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