Recall Z-2622-2025— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-2622-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-15

Class II · Ongoing

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2025-08-15. It names one FDA 510(k) clearance: K213799. 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..

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Ongoing
Initiated: 2025-08-15
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K213799 — N Series Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2022-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.