BeneVision N1 Patient Monitor — Class II medical device recall Z-2622-2025
Ongoing recall by Mindray DS USA, Inc. dba Mindray North America, reported 2025-10-01, distributed nationwide. Potential for activation of an abnormal alarm pause.
| Recall number | Z-2622-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2025-08-15 |
| Classified | 2025-09-25 |
| Reported by FDA | 2025-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,278 units |
| UPC / GTIN / UDI-DI | 06944904094922 |
| Serial numbers | AA3-01012322, AA3-01012323, AA3-01012324, AA3-01012325, AA3-01012326, AA3-01012327, AA3-01012328, AA3-01012329, AA3-01012330, AA3-01012331, AA3-01012332, AA3-01012333, AA3-01012334, AA3-01012336, AA3-01012337, AA3-01012338, AA3-01012339, AA3-01012340, AA3-01012341, AA3-01012342, AA3-01012343, AA3-01012344, AA3-01012345, AA3-01012346, AA3-01012347 and 475 more |
| Model numbers | 6660E-PA00010, 6660E-PA00011, 6660E-PA00012, 6660E-PA00014, 6660E-PA00015, 6660E-PA00016, 6660E-PA00017, 6660E-PA00018, 6660E-PA00019, 6660E-PA00020, 6660E-PA00021, 6660E-PA00030, 6660E-PA00031, 6660E-PA00032, 6660E-PA00035, 6660E-PA00041, Q6660E-PA00010, Q6660E-PA00011, Q6660E-PA00012, Q6660E-PA00018, Q6660E-PA00021 |
Product
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Reason for recall
Potential for activation of an abnormal alarm pause.
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-2622-2025. 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.