Medical device specifications
Recall Date : 8/5/2019
Recall Class : 1
Common Device  Name: Steam Sterilizer Unit
Brand Device Name : -
Producer company : صنایع هورتاب
Manufacturing Country : IRAN, ISLAMIC REPUBLIC OF
Model : تمامی مدل ها
Serial No. : تمامی شماره سریال ها
Importer / manufacturer company : hourtab
Recall Reason : - عدم تطابق دما و فشار دستگاه با مقادیر استاندارد - عدم ایجاد خلاء به صورت اتوماتیک - باز شدن درب اتوکلاو در حین اجرای سیکل - وجود نشتی در زیر درب استریل
Describe the quality problem
Date of reporting : 11/6/2018
History of the accident : -
Report type: Product Problem
Reporter Group : National Medical Device Directorate
Survey Results
Corrective action taken :
Recall Status : Open
Description : اقدام اصلاحی توسط شرکت سازنده: جمع آوری کلیه دستگاه‌های منصوب و جبران خسارات مربوطه نکات قابل توجه جهت کاربران: عدم استفاده از دستگاه‌های موجود تا زمان اجرای اقدام اصلاحی توسط شرکت سازنده
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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