Medical device specifications
Recall Date : 8/18/2018
Recall Class : 1
Common Device  Name: Automated External Defibrillator (AED) Unit
Brand Device Name :
Producer company : PHILIPS MEDICAL SYSTEMS
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 :
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.



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