Medical device specifications
Recall Date : 8/18/2018
Recall Class : 1
Common Device  Name: Automated External Defibrillator (AED) Unit
Brand Device Name :
Manufacturing Country : NETHERLANDS
Model :
Serial No. : تمامی شماره سریال ها
Importer / manufacturer company : Tajhiz Gostaresh Sina
Recall Reason : در صورت کارکرد دستگاه با باتری (بدون اتصال به برق شهر)، ممکن است به دلیل وجود مشکلات نرم افزاری و یا سخت افزاری، دستگاه قادر به ارائه شوک یا ضربان سازی نباشد.
Describe the quality problem
Date of reporting : 7/3/2018
History of the accident : -
Report type: Product Problem
Reporter Group : National Medical Device Directorate
Survey Results
Corrective action taken : Notification/Modification / Adjustment
Recall Status : Open
Description :

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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