Recall Z-0235-2020 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
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 phys
| Date | Oct 1, 2019 |
| Status | Terminated |
| Reason | 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 |
| Root cause | No Marketing Application |
| Action | Mindray communicated by letter on 10/1/19 to consignees and distributors by certified postal mail with return receipt verification: to consignees that have affected vital sign monitor; communication to consignees that purchased directly NIBP valve assembly boards; communication to distributors that have affected vital sign monitor. Consignees were instructed to contact Mindrays Repair Center to arrange for affected units to be returned for a software update. |
| Quantity | 13 units |
| Distribution | US Nationwide distributions. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132037 | VITAL SIGNS MONITOR Mindray North America, May 16, 2014 |