Recall Z-0114-2027— Mindray DS USA, Inc.
Class III · Ongoing
Class III FDA medical device recall by Mindray DS USA, Inc., initiated 2026-08-31. It names 2 FDA 510(k) clearances: K190011, K153448. Product: Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V. 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
2 on FDA's record- K190011 — Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
- K153448 — Passport Series Patient Monitors (Including Passport 8, Passport 12)
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
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
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.