Canon Medical System, USA, INC.: Medical Device Recall in 2020 - (Recall #: Z-2885-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 8, 2020

Date Posted: September 2, 2020

Recall Number: Z-2885-2020

Event ID: 86077

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.

Status: Ongoing

Product Quantity: 11 units

Code Information:

The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated