FA1183 Wireless Recharger (WR9200, WR9220) Unresponsive

 

 

Affected Medical Device : Activa RC (Model 37612)
RestoreSensor SureScan MRI (Model 97714)
Recharge System RS6200 Activa RC INS DBS

 

MDA Reference Number : MDA/FCA/2021-P162

 

MDA Registration Number : 

GD95662207017
GD23180629018

 

Decription : 

The Medtronic WR9200 recharger, contained within the Recharger Kit RS6200, have had occurrences where the WR device becomes unresponsive.

 

Local Establishment Contact Detail :

Athirah Abu Bakar
Regulatory Affairs Contingent
Medtronic
B-23-01, The Ascent, Paradigm
No. 1, Jalan SS7/26A,
47301 Petaling Jaya,
Selangor Darul Ehsan, Malaysia
Office +603-78838034 | Fax +603-78860474/4702

 

Email : athirah.abu.bakar@medtronic.com