ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Summary
The FDA issued a Class III for ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ eP by Mindray DS USA, Inc.. Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm f.
Details
Source
Device Recall
External ID
Z-0109-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Lot/Code Info: Part numbers of ePM Series Patient Monitors Operator's Manuals: 1. Guardian Plus Operator's Manual (OEM, MDPro) up to and including revision 4.0; Part No. 046-026408-00 2. ePM 10A Operator's Manual up to and including revision 12.0; Part No. 046-019796-00 3. ePM 12MA Operator's Manual up to and including revision 13.0; Part No. 046-019797-00 4. ePM 10M, ePM 12M Operator's Manual up to and including revision 13.0; Part No. 046-019798-00 5. ePM 15M Operator's Manual up to and including revision 3.0; Part No. 046-028915-00
Quantity Affected: 32,184 units
Reason for Recall
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Distribution
Worldwide - Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-31
Company
Mahwah, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Mindray DS USA, Inc. has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mindray DS USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mindray DS USA, Inc. have FDA actions?
Mindray DS USA, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0109-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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