cPM Series Patient Monitor Recall
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was cPM Series Patient Monitor recalled?
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
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
- Agency record number
- Z-0115-2027
- Product
- cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
- Recalling firm
- Mindray DS USA, Inc.
- Quantity
- 1,699 units
- Distribution
- Worldwide - Nationwide and the country of Canada.
- Recall started
- August 31, 2026
- Report date
- October 14, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)