Aquastop valve replacement for Heinemann MODULA series ENT Treatment Units (Easmed Internal No. MY-CAPA-2021-03 / MAL-FSCA-2021-01, Heinemann No. FSCA-AQ-HM-10052021_Rev1.0_EN)

 

Affected Medical Device : Heinemann MODULA ENT Diagnostic and Treatment Unit MOD20-330, MOD20-366

 

MDA Reference Number : MDA/FCA/2021-P116

 

MDA Registration Number : GB55123199317

 

Decription : Faulty component (manufacturing defect at the supplier) could cause thetreatment unit to fail. The fault would occur on the Aquastop valve and cause the water supply to fail, and thus functions such as suction systems, ear irrigation or tube rinsing.

 

Local Establishment Contact Detail :

Sim Sing Yee
Regulatory Affairs & Quality Assurance (RAQA)
Easmed Sdn Bhd
6th Floor, Suite 6.01 & 6.02, Menara Summit,Persiaran Kewajipan, USJ 1,47600 UEP Subang Jaya,Selangor Darul Ehsan, Malaysia.
(603) 8025 9328

Email : singyee.sim@easmed.com

 

 A copy of FSN.