FSCA Notice CAPA-HER-MD-21-002 - Surgical Microscope Leica Microscope M220 F12 : Additional Retention Fixture to secure M220 Optics Carrier

 

 

Affected Medical Device : Surgical Microscope Leica M220 F12

 

MDA Reference Number : MDA/FCA/2021-P168

 

MDA Registration Number : GMD74389460918A

 

Description :

The M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient. The identified defect is a mechanical part failure with the screw that connects the optics carrier to the free end of the swing arm. As a matter of precaution Leica Microsystems has chosen to initiate a field safety corrective action to provide a retention fixture (see Figure 3) to be added on all Leica M220 F12 Surgical Microscopes manufactured before March 9th, 2017 to ensure patient safety and customer satisfaction.

 

Local Establishment Contact Detail :

Salasiah
Schmidt BioMedTech Sdn Bhd
5th Floor Wisma Tecna, 18A Jalan 51A/223, 46100 Petaling Jaya, Selangor
03 7844 9000

 

Email : salasiah@schmidtbmt.com