FDA Device recall Z-0115-2027
cPM Series Patient Monitor
- FDA Device
- Class III
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class III recall of cPM Series Patient Monitor by Mindray Ds Usa, citing certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0115-2027 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-08-31 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Mindray Ds Usa |
| Distribution | US |
Product
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Reason
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Identifiers
| code_info | Part Numbers of the cPM Series Patient Monitor Operator's Manual: 1. cPM 12/cPM 8 Operator's Manual up to and including revision 4.0; Part No. 046-011732-00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
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 - ePM Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa - Passport 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-0115-2027%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.