Recall Z-0109-2027
- Recall number
- Z-0109-2027
- Event number
- 99828
- Firm
- Mindray DS USA, Inc.
- Firm FEI
- 2221819
- Product code
- MHX
- Status
- Open, Classified
- Initiated
- 2026-08-31
- Posted
- 2026-10-07
- Root cause
- Labeling design
- 510(k) numbers
- K260098, K102040, K033711, K093268, K033600, K000854, K113653, K061185, K000517, K173768, K100040, K192514, K080495, K252250, K040395, K942700, K051400, K132077, K040955, K990068, K040357, K073462, K131414, K102376, K131829, K001722, K250349, K082045, K950264, K260579
Product#
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Reason for Recall#
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions