Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 6100F- PA00195 6100F- PA00197 6100F- PA00219 6100F- PA00221 6100F- PA00267 6100F- PA00269 6100F- PA00291 6100F- PA00293
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Mindray DS USA, Inc. dba Mindray North America
- Reason for Recall:
- An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Product Codes/Lot Numbers:
6100F- PA00195 6100F- PA00197 6100F- PA00219 6100F- PA00221 6100F- PA00267 6100F- PA00269 6100F- PA00291 6100F- PA00293
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1280-2015
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