Mindray DS USA, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Part numbers of BeneVision N1 and N-Series Patient Monitors Operator's Manuals: 1. BeneVision N1 Operator's Manual up to and including revision 21.0; Part No. 046-011405-00. 2. BeneVision N-Series Operator's Manual up to and including revision 23; Part No. 046-011259-0.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →