Voalte Nurse Call System provides a comprehensive communication and… — Class II medical device recall Z-1094-2022
Terminated recall by Baxter Healthcare Corporation, reported 2022-05-25, distributed in NC, VA. Firm discovered a firmware memory leak with a supplier-manufactured component.
| Recall number | Z-1094-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-04-13 |
| Classified | 2022-05-13 |
| Reported by FDA | 2022-05-25 |
| Terminated | 2023-12-20 |
| Distributed | NC, VA |
| Quantity | 1,414 units |
| Reason classes | packaging, software |
| UPC / GTIN / UDI-DI | 00887761995079 |
| Model numbers | 4.0 |
Product
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Reason for recall
Firm discovered a firmware memory leak with a supplier-manufactured component.
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-1094-2022. 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.