SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCAR Recall

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Reference Number:	mdprc 011 09 11 000
Date submitted:	9/5/2011

Manufacturer:	Institut Straumann
Device Type:	Picture archiving and communication system, coDiagnostiX
Description:	Picture archiving and communication system, radiology
Medical Device Identifier:	Model: 019.0370; 019.0371; 019.0372; 019.0373; 019.0378; 019.0379; 019.0380; 019.0381; 019.0382; 019.0383; 019.0384; 019.0385; 019.0386; 019.0387; 019.0388; 019.0389; 019.0390; 019.0391; 019.0392; 019.0393 (Attached)
Reason of Field Safety Corrective Action:	The issue occurs if the implant length is changed after the 2.8mm sleeve planning has been completed.
Remedy Action:	Unless the software update is available, users should manually the surgical protocol before performing the guided procedure.
Athorized Representative/Importer/Distributor:	N/A
Report Source:	NCAR
Source Ref. Number:	CH-2011-08-09-026
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Institut Straumann.pdf

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