Mindray Recalls Passport Series Patient Monitor Operator's Manuals
Mindray DS USA, Inc. is recalling Passport Series Patient Monitor operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.
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 recall is classified as Class III, and the source text identifies the hazard as insufficient or unclear descriptions in the operator's manuals regarding physiological alarm functions. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Mindray DS USA, Inc. is recalling 39,891 units of Passport Series Patient Monitor operator's manuals. The affected manuals include the Passport 8/12, Passport 17M/12M, and Passport V models, specifically those up to and including the revisions listed in the recall notice.
The recall was initiated because certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions. The affected products were distributed worldwide, including nationwide in the United States and in Canada.
The source text does not provide specific instructions for consumers or healthcare providers on how to proceed with this recall, nor does it report any illnesses, injuries, or deaths associated with the use of these manuals.
The recalled product
- Product
- Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
- Manufacturer
- Mindray DS USA, Inc.
- Hazard
- Affected units
- 39,891
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. 0070-00-0704-02
Distribution
Distributed nationwide across the United States.
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