التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

The Operations Manual and Service Manual for the DM3 and DM4 have been updated by Spacelabs Healthcare to convey the risks associated with continuing to use the lithium batteries past the specified use life and to clarify that batteries older than two years, damaged, or that are no longer holding a charge must be replaced.
Users must download current versions of the Operations Manual and Service Manual and dispose of any previous copies. The updated product labeling is available via the Spacelabs user manual site at https://manuals.spacelabshealthcare.com/.
Biomedical engineering must remove and replace any batteries that have been in use longer than two years, are damaged, or are no longer holding a charge. Contact Spacelabs Service to arrange for battery replacement, refer to the attachment for more information.
Biomedical engineering must arrange preventive maintenance to replace the batteries upon reaching the conclusion of their two-year use life.

Manufacturer action: Instructions and correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-21-07-25-967