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
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

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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

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