Recall Z-2885-2020— Canon Medical System, USA, INC.

Name: FDA recall Z-2885-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-08

Class II · Ongoing

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2020-07-08. It names one FDA 510(k) clearance: K181834. Product: System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147. 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: Canon Medical System, USA, INC.
Classification: Class II
Status: Ongoing
Initiated: 2020-07-08
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K181834 — Ultimax-i, DREX-UI80 (V1.60)Canon Medical Systems Corporation·cleared 2018-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.