Medical device specifications
Recall Date : 2/12/2019
Recall Class : 2
Common Device  Name: digital fluoroscopys
Brand Device Name : -
Producer company : STEPHANIX s.a
Manufacturing Country : FRANCE
Model :
Serial No. : تمامی شماره سریال ها
Importer / manufacturer company : Payamed Electronic Industries
Recall Reason : ایجاد جابجایی و حرکت ناخواسته در تخت دستگاه به دلیل مشکلات نرم افزاری
Describe the quality problem
Date of reporting : 2/4/2019
History of the accident : -
Report type: Product Problem
Reporter Group : National Medical Device Directorate
Survey Results
Corrective action taken :
Recall Status : Open
Description : دارندگان دستگاه فلوروسکوپی با مشخصات فوق الذکر جهت برطرف سازی اشکال نرم افزاری با نماینده کمپانی تماس بگیرند. درصورت مشاهده هرگونه حرکت غیرمعمول سریعا دکمه توقف اضطراری فشار داده شود.

The recall of medical Device is classified into three classes according to the severity of the risks of their safety and performance problems:
Class 1: The most serious type of call. In this class there is a possibility of serious injury and death.
Class 2: Potential damage is temporary and reversible, or the probability of serious injury and death is negligible.
Class 3: The possibility of damage is negligible, while the labeling rules or documents accompanying the General Office or the manufacturer have been violated.

All Rights Reserved Medical Device Directorate of Islamic Republic of Iran.

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