Patient monitors recalled over potential activation of an abnormal alarm pause
BeneVision N1 Patient Monitors are recalled because of the potential for activation of an abnormal alarm pause. 2,278 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an unexpected alarm pause on a patient monitor is a potential harm and no injuries are reported.
Plain-English summary
The BeneVision N1 Patient Monitor is being recalled across part numbers including 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011 and Q6660E-PA00011, with UDI-DI 06944904094922 and the software versions listed in the recall notice. The recall covers 2,278 units distributed nationwide in the United States and in Canada.
The recall was issued because of the potential for activation of an abnormal alarm pause. The FDA classified the action as Class II.
Hospitals operating these monitors should follow the manufacturer's instructions for the correction and should remain alert to alarm status on affected units.
The recalled product
- 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, Q
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Hazard
- alarm-pause
- patient-monitoring
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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