System Model: Ultimax-i — Class II medical device recall Z-2885-2020
Ongoing recall by Canon Medical System, USA, INC., reported 2020-09-02, distributed in CA, CT, ID, LA, MT, NV, OH, SC…. During a procedure, when images were acquired, and these images were transferred to PACS /image archival syste
| Recall number | Z-2885-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Medical System, USA, INC., Tustin, CA, United States |
| Recall initiated | 2020-07-08 |
| Classified | 2020-08-25 |
| Reported by FDA | 2020-09-02 |
| Distributed | CA, CT, ID, LA, MT, NV, OH, SC, WI, WV |
| Quantity | 11 units |
| UPC / GTIN / UDI-DI | 04987670100147 |
| Model numbers | DREX-UI80, HDR-08A |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2885-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.