FDA Device recall Z-2885-2020
System Model: Ultimax-i, DREX-UI80 (DREX-UI80)
- FDA Device
- Class II
- ongoing
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II recall of System Model: Ultimax-i, DREX-UI80 (DREX-UI80) by Canon Medical System Usa, citing 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 acq….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2885-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-08 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Canon Medical System Usa |
| Distribution | CA, CT, ID, LA, MT, NV, OH, SC, WI, WV |
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.
Identifiers
| code_info | The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2…The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2885-2020%22
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