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