Mindray Ds Usa, Inc.: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Recall Summary Mindray DS USA is recalling operator's manuals for BeneView Series T5 and T8 patient monitors because the manuals don't adequately describe or clarify how certain physiological alarm functions work. The recall affects BeneView monitors distributed nationwide in the U.S. and Canada. This is a Class II recall, meaning the manuals could potentially cause user confusion about alarm operation, though it is not classified as an immediate safety threat.
- Recalling firm
- Mindray DS USA, Inc.
- Product
- BeneView Series. Operator's Manuals: T5 / T8
- Reason
- Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-31
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - Nationwide and the country of Canada.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f3084efb-2adb-40f2-ba7a-aa657e95d163