FIELD SAFETY NOTICE 2021-004M Software update Notification for CV-1500 and resumption of use with EZ1500 series endoscopes

 

Affected Medical Device : 

Video System Center

Video System Center

 

MDA Reference Number : MDA/FCA/2021-P107

 

MDA Registration Number : GB2460720-48587

 

Decription : Unintentional thermal tissue damage associated with excessive light irradiation from the illumination light of the CF-EZ1500DI and GIF-EZ1500.

 

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.