Official recall notice
FDA DeviceClass IIINotable
cPM Series Patient Monitor Recall (Oct 2026) – Mindray DS USA
Product: cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
- Recall date
- 2026-10-14
- Brand
- Mindray DS USA, Inc.
- Category
- Medical Device
- FDA class
- Class III
Why it was recalled
Hazard
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Product description
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Affected products
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