Field Safety Notice MI506/21/S : Biograph, Biograph Truepoint, Biograph MCT - Improper use of the Patient Handling System (PHS) Pallet/Foot Extension

 

 

Affected Medical Device : Biograph, Biograph Truepoint, Biograph MCT

 

MDA Reference Number : MDA/FCA/2021-P153

 

MDA Registration Number : 

GC28010431417
GC79074213017

 

Decription :

Potential patient fall hazards could occur when the PHS Pallet/Foot Extension is improperly assembled by the operator. PHS Pallet/Foot Extension patient fall hazards could occur when the extension is improperly used to position the patient head-first. The Pallet/Foot Extension should only be used for positioning the patient’s feet.

 

Local Establishment Contact Detail :

Nur Ayuni Abas
Siemens Healthcare Sdn. Bhd.
SHS AP ASN MAS QT
Level 16, CP Tower,No. 11, Jalan 16/11,Pusat Dagang Seksyen 16,46350 Petaling Jaya, Selangor, Malaysia
Tel.: +60 3 7952-5236
Fax: +60 3 7955-7331

Email : nur-ayuni.abas@siemens-healthineers.com

 A copy of FSN.