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Mindray DS USA, Inc. dba Mindray North America recalls BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00
Recalled October 1, 2025 · FDA recall Z-2622-2025 · Mindray DS USA, Inc.
Hazard
Potential for activation of an abnormal alarm pause. · FDA Class II
Units
2,278 units
Sold at
Worldwide - Nationwide distribution and the country of Canada.
Description
Potential for activation of an abnormal alarm pause.
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.
Manufacturer(s)
Mindray DS USA, Inc. dba Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →