iConnect Access used with Ortho PACS software provides medical… — Class II medical device recall Z-2532-2016
Terminated recall by Merge Healthcare, Inc., reported 2016-08-24, distributed nationwide. Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the corre
| Recall number | Z-2532-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2016-01-30 |
| Classified | 2016-08-12 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2021-05-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | NZ |
| Quantity | 146 sites |
Product
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Reason for recall
Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.
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-2532-2016. 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.