Rosie4 Vital Signs Monitor with NIBP valve assembly recall
Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is…
Why was Rosie4 Vital Signs Monitor with NIBP valve assembly recalled?
NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5
- Product
- Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is…
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Quantity
- 14 units
- Distribution
- US Nationwide distributions.
- Recall date
- November 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)