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U.S. Department of Health and Human Services

Class 2 Device Recall Accutorr 7 Vital Signs Monitor

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  Class 2 Device Recall Accutorr 7 Vital Signs Monitor see related information
Date Initiated by Firm October 01, 2019
Create Date October 29, 2019
Recall Status1 Terminated 3 on August 06, 2021
Recall Number Z-0236-2020
Recall Event ID 83979
510(K)Number K182821  
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
Product Accutorr 7 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
Code Information NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact SAME
800-288-2121
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 107 units
Distribution US Nationwide distributions.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = Shenzhen Mindray Bio-medical Electronics Co., LTD.
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