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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 124 07 18 000
Date submitted: 7/24/2018
Manufacturer:Abbott
Device Type:ARCHITECT c4000, c8000 and c16000 Processing Module
Description:Instrumentation
Medical Device Identifier:ARCHITECT c4000 Processing Module : 02P24

ARCHITECT c8000 Processing Module : 01G06

ARCHITECT c16000 Processing Module : 03L77
Reason of Field Safety Corrective Action:The ARCHITECT pressure monitoring system helps identify errors during pipetting operations, and error messages are generated to alert the user, should a problem with this system occur. If the system is in the Running status when pressure monitoring error code 3586 to 3600 or 5381 is generated, the ARCHITECT takes appropriate action to protect the integrity of patient test(s). If communication is lost between the ARCHITECT and the pressure monitoring system, the processing module will be placed into the Stopped status until the issue can be addressed. This ensures all tests are monitored by the pressure monitoring system.
Remedy Action:Abbott recommends one of the following actions to ensure the pressure monitoring is enabled on your system
1. Review your ARCHITECT’s message history for general error code 0529 “c System module powered ON”. Note the date of the last time the power was cycled. (If there are no occurrences of code 0529, proceed to step 2). Then review your message history for error codes 3580 to 3585 or 5381 back to the date of the last time the system power was cycled. If one or more of these errors is present, cycle power to the ARCHITECT (see instructions in item 2). If no errors are present, no further action is required.
‐or‐
2. Cycle the power on the ARCHITECT. This will allow the ARCHITECT to attempt to reestablish communication to the pressure monitor board. If the ARCHITECT produces error codes 3580 to 3585 or 5381 after system startup, contact Abbott customer service.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:E3A43FE6E8394
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott 3.pdf