Mindray DS USA, Inc. recalls Passport Series Patient Monitor. Operator's Manuals: 8 / 12
See all recalls from Mindray DS USA, Inc. →Recalled Product
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Hazard / Issue
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Part Numbers of Passport Series Patient Monitor Operator's Manuals: 1. Passport 8_12 Operator's Manual up to and including revision 13.0; Part No. 046-004417-00 2. Passport 17M 12M Operator's Manual up to and including revision 17.0; Part No. 046-005013-00 3. Passport V Patient Monitors Operating Instructions up to and including revision 10.0; Part No. 0070-00-0704-02
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Passport Series Patient Monitor. →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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