Recall Z-0112-2027
- Recall number
- Z-0112-2027
- Event number
- 99828
- Firm
- Mindray DS USA, Inc.
- Firm FEI
- 2221819
- Product code
- MSX
- Status
- Open, Classified
- Initiated
- 2026-08-31
- Posted
- 2026-10-07
- Root cause
- Labeling design
- 510(k) numbers
- K242728, K142935, K193391, K061994, K071047, K071391, K052972, K140852, K012171, K111296, K210160, K070421, K030615, K052975, K110521, K143057, K220058, K994430, K062278, K121865, K153156, K232548, K971868, K102974, K003998, K192952, K151006, K061428, K242750, K000647
Product#
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Reason for Recall#
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions