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U.S. Department of Health and Human Services

Class 2 Device Recall A3/A5 Anesthesia System

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  Class 2 Device Recall A3/A5 Anesthesia System see related information
Date Initiated by Firm July 14, 2017
Create Date March 02, 2018
Recall Status1 Terminated 3 on April 17, 2019
Recall Number Z-0846-2018
Recall Event ID 79133
510(K)Number K123211  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5)

Product Usage:
The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The A-Series is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used for adult, pediatric, and infant populations.
Code Information Units distributed or upgraded between March 2013 and December 21, 2016. Serial numbers requested.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Diane Arpino
201-995-8407
Manufacturer Reason
for Recall		 A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
FDA Determined
Cause 2		 Device Design
Action Mindray sent an Urgent Medical Device Correction letter dated June 9, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Corrective Action: In order to eliminate any potential for the EEPROM issue to manifest, Mindray is offering two options for upgrading affected systems in your facility: Option 1: You may perform the software upgrade if your facility has Biomedical Engineering or other staff that have been trained by Mindray to perform maintenance operations on the ASeries. Please contact Mindray's Technical Support team who will assist with providing the software and instructions for performing the software upgrade. The Technical Support can be reached at (877) 913-9663 (Option 1). Option 2: A Mindray Service Representative will upgrade the affected systems in your facility at no charge. Please contact your Mindray Service Representative to arrange for this upgrade at (877) 913-9663 (Option 8). Both the Technical Support and Service teams may be reached Monday through Friday, 8:30am - 5:30pm, ET.
Quantity in Commerce 2875 in total
Distribution Worldwide Distribution - US Nationwide
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 = BSZ and Original Applicant = DATASCOPE CORP., PATIENT MONITORING DIVISION
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