Recall Z-0113-2027— Mindray DS USA, Inc.

Name: FDA recall Z-0113-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-31

Class III · Ongoing

Class III FDA medical device recall by Mindray DS USA, Inc., initiated 2026-08-31. It names one FDA 510(k) clearance: K092449. 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.

Recalling firm: Mindray DS USA, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2026-08-31
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K092449 — BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2010-08-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BeneView Series. Operator's Manuals: T5 / T8

Reason for recall

Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

Data sourced from openFDA. This site is unofficial and independent of the FDA.