Recall – PACS system missing images

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

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course sponsored by the Irish Medtech Association / Ibec, Connected Health Skillnet.  November 19, 2020, 9 am to 6 pm IST.  Read more and registration information:  Agile methods Flyer (19 Nov)

Registration Link:  https://connectedhealthskillnet.ie/IBEC/Events.nsf/

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.