Reported Oct 14, 2026 · Ongoing · Updated Oct 20, 2026
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Mindray DS USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. · 800 Macarthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
- cPM Series Patient Monitor
- Operator's ManualcPM 8/cPM 12
- Lot codes and dates
- Part Numbers of the cPM Series
- Patient Monitor Operator's Manual1. cPM 12/cPM 8 Operator's Manual up to and including revision 4.0; Part No. 046-011732-00
- Amount recalled
- 1,699 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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