Certain Mindray patient monitor manuals need clarification of alarm functions
Certain operator's manuals for Mindray BeneVision N1 and N-Series patient monitors contain descriptions that may be insufficient or need clarification about selected physiological alarm functions.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The issue is insufficient or unclear documentation for selected physiological alarm functions, and the source does not report any illnesses, injuries, or deaths. The recall is classified as FDA Class III.
Plain-English summary
The recall covers certain operator's manuals for Mindray BeneVision N1 and N-Series patient monitors, including the N12, N15, N17, N19 and N22. The source lists 44,651 units and describes distribution as “Worldwide - Nationwide and the country of Canada.”
The affected manuals are the BeneVision N1 Operator's Manual up to and including revision 21.0, part number 046-011405-00, and the BeneVision N-Series Operator's Manual up to and including revision 23, part number 046-011259-0. The recall reason is that descriptions in certain manuals may be insufficient or may require clarification about selected physiological alarm functions.
The supplied source does not state a specific corrective action, including whether manuals should be removed or replaced. Users can determine whether a manual is listed by comparing its part number and revision with the affected manual groups above.
The recalled product
- Product
- BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
- Manufacturer
- Mindray DS USA, Inc.
- Hazard
- Affected units
- 44,651
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 (1)
- Part No. 046-011259-0.
Distribution
Distributed nationwide across the United States.
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