FDA Device recall Z-1611-2014
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming…
- FDA Device
- Class II
- terminated
- Published 2014-05-21
On 2014-05-21 the FDA classified a Class II recall of DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming… by Mindray Ds Usa, citing the MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1611-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-05 |
| Published | 2014-05-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
Product
DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)
Reason
The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
Identifiers
| code_info | monitor p/n 6802F-PA00001 module p/n 115-001704-00/M51A-30-80876 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Mindray Ds Usa
- T1 Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - BeneVision Series Telemetry Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - BeneVision N1 and N-Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - cPM Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - ePM Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1611-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.