Z-2885-2020Class II

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

Name: Z-2885-2020 System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Creator: Canon Medical System, USA, INC.
Published: 2020-07-08
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2020-07-08 / Open, Classified / root cause: software

FDA source

Canon Medical System, USA, INC. began a recall of System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147 on 2020-07-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2885-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-08
Posted: 2020-08-25
Recalling firm: Canon Medical Systems USA, Inc.
Product: System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: software
FDA root cause: Software design
Action: The recall letters were sent via facsimile between 07/08-10/2020. The letter contains a return reply form that is to be completed by the customer and faxed to CMSU for retention. After approximately one month contact will be made with each non-responding location and a copy of the letter will be faxed to that location and the fax receipt will serve as proof of notification.
Quantity in commerce: 11 units
Distribution: US - CA, CT, ID, LA, MT, NV, OH, SC, WI and WV
Product codes and lots: The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2885-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2885-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-02	2020-08-25

Product code OWB

K181834Class IIUltimax-i, DREX-UI80 (V1.60)Canon Medical Systems Corporation / cleared 2018-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)