Mindray T1 Patient Monitor Operator's Manual Recall for Alarm Descriptions
Mindray DS USA, Inc. is recalling T1 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, and the source describes the hazard as insufficient or unclear descriptions in the operator's manual regarding alarm functions. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Mindray DS USA, Inc. is recalling 4,946 units of the T1 Patient Monitor Operator's Manual. The recall covers manuals up to and including revision 14.0, identified by Part No. 046-006734-00.
The recall was initiated because the manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions. The affected manuals were distributed nationwide in the United States and in Canada.
The source text does not provide specific instructions for consumers on how to proceed with the recall or how to obtain replacements.
The recalled product
- Product
- T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
- Manufacturer
- Mindray DS USA, Inc.
- Hazard
- Affected units
- 4,946
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. 046-006734-00
Distribution
Distributed nationwide across the United States.
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