FDA Device recall Z-2622-2025
BeneVision N1 Patient Monitor (N1)
- FDA Device
- Class II
- ongoing
- Published 2025-10-01
On 2025-10-01 the FDA classified a Class II recall of BeneVision N1 Patient Monitor (N1) by Mindray Ds Usa, citing potential for activation of an abnormal alarm pause.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2622-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-15 |
| Published | 2025-10-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
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
Potential for activation of an abnormal alarm pause.
Identifiers
| code_info | Below configurations of the Benevision N1 patient monitor (UDI-DI: 06944904094922) with software version versions 01.04…Below configurations of the Benevision N1 patient monitor (UDI-DI: 06944904094922) with software version versions 01.04.00.01, 01.05.00.01, 01.06.00.01, 01.06.01.01: 1. N1 Nellcor: Part Number: 6660E-PA00010; Serial Numbers: AA3-06023768, AA3-06023476, AA3-03014849. 2. Used N1 Nellcor: Part Number: Q6660E-PA00010; Serial Numbers: AA3-8C003924. 3. N1 Nellcor, ST: Part Number: 6660E-PA00011; Serial Numbers: AA3-92004799, AA3-06023994, AA3-03014853, AA3-03014857, AA3-03014701, AA3-03014714, AA3-03014848, AA3-03014850, AA3-03014861, AA3-03014865, AA3-04017814, AA3-06024001, AA3-03014700, AA3-03014702, AA3-03014703, AA3-03014705, AA3-03014707, AA3-03014710, AA3-03014854, AA3-03014859, AA3-03014862, AA3-03014864, AA3-03014867, AA3-9C011900, AA3-9C011901, AA3-9C011905, AA3-9C011916, AA3-9C011918, AA3-9C011920, AA3-02013653, AA3-02013654, AA3-02013655, AA3-02013656, AA3-02013657, AA3-07024289, AA3-94006408, AA3-97007795, AA3-98008764, AA3-98008766, AA3-98008774, AA3-98008789, AA3-98008799, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2622-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.