FDA Medical devices recall ·
BeneVision N1 Patient Monitor (N1) recall
- Recall number
- Z-2622-2025
- Date
- (initiated August 15, 2025)
- Company / brand
- Mindray North America
800 Macarthur Blvd, Mahwah, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,278 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for activation of an abnormal alarm pause.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, AA3-98008801, AA3-98008802, AA3-9C011260, AA3-9C011240, AA3-9C011242, AA3-9C011249, AA3-9C011259, AA3-03014712, AA3-05021468, AA3-97007785, AA3-97007786, AA3-97007787, AA3-97007788, AA3-97007789, AA3-97007790, AA3-97007791, AA3-97007792, AA3-97007794, AA3-97007796, AA3-97007797, AA3-97007798, AA3-97007799, AA3-97007800, AA3-97007801, AA3-97007802, AA3-97007803, AA3-97007804, AA3-97007805, AA3-97007806, AA3-97007808, AA3-97007809, AA3-97007810, AA3-97007811, AA3-97007812, AA3-97007813, AA3-97007814,
Distribution
Worldwide - Nationwide distribution and the country of Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2622-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.