Z-0235-2020 Class II Terminated
FDA device recall Z-0235-2020 was initiated by Mindray DS USA, Inc. dba Mindray North America on October 1, 2019 and is designated Class II. 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 The recall status is terminated (terminated August 6, 2021). Affected quantity: 13 units.
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
- 13 units
Product Description
Accutorr 3 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 spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), and Temperature (TEMP) on adult, pediatric, and neonatal patients in 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