United StatesWhat's being recalled
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.
Recalling firm: Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States.
How to identify it
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, AA3-97007815, AA3-97007816, AA3-97007817, AA3-97007818, AA3-97007819, AA3-97007821, AA3-97007822, AA3-97007823, AA3-97007824, AA3-97007825, AA3-97007826, AA3-97007827, AA3-97007828, AA3-97007829, AA3-98008767, AA3-98008772, AA3-98008773, AA3-98008806, AA3-98008807, AA3-98008808, AA3-98008809, AA3-98008810, AA3-98008811, AA3-98008812, AA3-98008813, AA3-98008814, AA3-98008816, AA3-98008817, AA3-98008818, AA3-98008819, AA3-98008821, AA3-98008822, AA3-98008823, AA3-98008824, AA3-98008825…
The hazard
Potential for activation of an abnormal alarm pause.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - Nationwide distribution and the country of Canada.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)