Mindray Recalls BeneView T5 and T8 Operator's Manuals for Alarm Clarification
Mindray DS USA, Inc. is recalling 133 BeneView T5 and T8 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 involves operator's manuals with descriptions that may be insufficient or require clarification regarding physiological alarm functions. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Mindray DS USA, Inc. is recalling 133 units of BeneView Series operator's manuals for the T5 and T8 models. The recall involves the BeneView T5 Operator's Manual up to and including revision 17.0 (Part No. 6802-20-66856) and the BeneView T8 Operator's Manual up to and including revision 16.0 (Part No. 6800-20-50710).
The recall was initiated because certain 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 specify the corrective action or instructions for consumers. Users of these manuals should contact Mindray DS USA, Inc. for further information regarding the recall and any necessary updates.
The recalled product
- Product
- BeneView Series. Operator's Manuals: T5 / T8
- Manufacturer
- Mindray DS USA, Inc.
- Hazard
- Affected units
- 133
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. 6800-20-50710
Distribution
Distributed nationwide across the United States.
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