Corrective action reporting for FMI 73091 : Vscan Extend - Battery Depletion

 

 

Affected Medical Device : Vscan Extend

 

MDA Reference Number : MDA/FCA/2021-P169

 

MDA Registration Number : GB52444533718

 

Description :

GE Healthcare has become aware of an issue where the Vscan Extend will not power on because of a depleted internal battery. This issue can occur if the device is not turned off prior to the external battery being removed or when connected to a Personal Computer (PC) without connecting to AC power. In these situations, the device is not available for use until it is connected to AC power and charged for approximately 10 minutes. This could cause a delay in treatment.

 

Local Establishment Contact Detail :

Benedict Lee
ASEAN Regulatory Affairs Specialist
GE Healthcare Sdn Bhd
Level 6, 1 Sentral, Jln Travers, KL Sentral, 50470 KL
03 22739788

 

Email : benedict.lee@ge.com

 

 A copy of FSN.