EyeSuite i — Class II medical device recall Z-1500-2017
Terminated recall by Haag-Streit USA Inc, reported 2017-03-29, distributed nationwide. There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-stand
| Recall number | Z-1500-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haag-Streit USA Inc, Mason, OH, United States |
| Recall initiated | 2017-01-05 |
| Classified | 2017-03-20 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2019-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 163 units |
| Model numbers | 7220374 |
Product
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Reason for recall
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
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-1500-2017. 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.