Mindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
Mindray DS USA is recalling ePM Series Patient Monitor operator's manuals because descriptions of 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 because the hazard involves insufficient or unclear descriptions in operator's manuals regarding alarm functions, which is not likely to cause adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Mindray DS USA, Inc. is recalling 32,184 units of ePM Series Patient Monitors, including the ePM 10M, ePM 12M, ePM 12MA, ePM 15M, and ePM 10A models. The recall involves specific operator's manuals for these devices that were distributed nationwide and in Canada.
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 manuals include the Guardian Plus Operator's Manual (up to revision 4.0), ePM 10A Operator's Manual (up to revision 12.0), ePM 12MA Operator's Manual (up to revision 13.0), ePM 10M/ePM 12M Operator's Manual (up to revision 13.0), and ePM 15M Operator's Manual (up to revision 3.0).
Healthcare facilities and users should contact Mindray DS USA, Inc. for instructions on how to obtain updated manuals or further information regarding the clarification of alarm function descriptions.
The recalled product
- Product
- ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
- Manufacturer
- Mindray DS USA, Inc.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 32,184
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 (4)
- MDPro) up to and including revision 4.0
- Part No. 046-019797-00 4. ePM 10M
- ePM 12M Operator's Manual up to and including revision 13.0
- Part No. 046-028915-00
Distribution
Distributed nationwide across the United States.
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