Julai 2021 : 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)
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 : [email protected]
