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Home › FDA recalls › cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
CLASS III · LowFDA

Mindray DS USA, Inc. recalls cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12

📅 Aug 31, 2026 · 📍 Nationwide
Recalling company
Mindray DS USA, Inc.
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
Classification
Class III – not likely to cause adverse health consequences
Recall date
Aug 31, 2026
Reported
Oct 14, 2026
Distribution
Worldwide - Nationwide and the country of Canada.
Status
Ongoing
Quantity
1,699 units
Lot / codes
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
Company location
Mahwah, NJ
Recall type
Voluntary: Firm initiated
Recall number
Z-0115-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0115-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.