X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 027 09 18 000
Date submitted: 9/12/2018
Manufacturer:Abbott
Device Type:Accelerator APS
Description:Accelerator
Medical Device Identifier:List Number: 07L01
Serial Numbers : All
Reason of Field Safety Corrective Action:The transport mechanism that moves the robot along the axes generates a magnetic field which may interfere with pacemaker/implanted heart defibrillator functionality at close distances. This affects all APS system serial numbers.
Remedy Action:Please be aware that personnel fitted with a pacemaker/implanted heart defibrillator must not handle or work on these modules at distances less than 200 mm even if the warning label is missing.
Abbott representative will be contacting you to schedule time to place a new hazard label on the APS modules. In the interim, please remove the last page of this letter and affix a copy of the label on the cover of these modules until the official pacemaker label is available.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:FBADD9CCCE41B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf