Company: Canon Medical System, USA, Inc.
Date of Enforcement Report: 9/2/2020
Class II

PRODUCT

System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147

Recall Number: Z-2885-2020

REASON

During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.

RECALLING FIRM/MANUFACTURER

Canon Medical System, USA, INC. on 7/8/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

11 units

DISTRIBUTION

U.S. Nationwide