FDA recall Z-2885-2020

Canon Medical System, USA, INC. · Class II · device

Product

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

Reason for recall

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.

Distribution

US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV

Key facts

Status: Ongoing
Initiation date: 2020-07-08
Report date: 2020-09-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2885-2020