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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 028 07 12 002
Date submitted: 7/21/2012
Manufacturer:Radiometer Medical
Device Type:Blood gas analyser, ABL90 FLEX
Description:Analyser, blood gas, general purpose
Medical Device Identifier:Software version: 2.7 MR3
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MHRA update code (software version):
ABL90 FLEX with software versions below V2.7 MR4 and using the HL7 V2.5 communication protocol for transmitting results to a HIS/LIS system.
Reason of Field Safety Corrective Action:If the connection between an ABL and a Hospital Information System is broken, the results are queued for later transmission. If the ABL and HIS are configured with the data transfer protocol HL7 version 2.5 any results in the queue will be mixed up when the instruments transmit the queue after reconnection. The root cause is the inherent software design.
Remedy Action:The manufacturer will issue a software upgrade
Athorized Representative/Importer/Distributor:Salehiya Trading Est., Riyadh, (01) 2628939
Report Source:NCAR
Source Ref. Number:DK-2012-07-06 -014
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Radiometer.pdf.pdf