Reported Oct 14, 2026 · Ongoing
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
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?
- Passport Series Patient Monitor
- Operator's Manuals8 / 12 / 12M / 17M / V
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 046-004417-00Passport 8_12 Operator's Manual up to and including revision 13.0 046-005013-00Passport 17M 12M Operator's Manual up to and including revision 17.0 0070-00-0704-02Passport V Patient Monitors Operating Instructions up to and including revision 10.0 - Amount recalled
- 39,891 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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