FCA Notification 2021-002M - Endoscope Label on Front Door of Olympus Endoscope ReprocessorOER-AW

 

Affected Medical Device : Endoscope Reprocessor OER-AW

 

MDA Reference Number : MDA/FCA/2021-P124

 

MDA Registration Number : GC2422865416

 

Decription : Incorrect labeling at the front door of OER-AW. The affected label is the “ENDOSCOPE COMBINATIONS FOR DUAL SCOPE REPROCESSING” label affixed on the front door of the OER-AW.

 

Local Establishment Contact Detail :

Shelly Yeoh
Assistant Manager, Regulatory Affairs | Medical Systems Business Division | Olympus (Malaysia) Sdn. Bhd.
TEL: (603) 7886 9188 | FAX: (603) 7887 2833 |

Email : seoching.yeoh@olympus-ap.com

 

 A copy of FSN.