Z-0237-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- October 1, 2019
- Termination Date
- August 6, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
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 intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians
Reason for Recall
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
Distribution Pattern
US Nationwide distributions.
Code Information
NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5