Medical device specifications
Recall Date : 6/27/2018 11:27:00 AM
Recall Class : 2
Common Device  Name: Syring Pump Unit
Brand Device Name :
Producer company : Atom Medical Corporation
Manufacturing Country : JAPAN
Model :
Serial No. : -
Importer / manufacturer company : RaymandRad
Recall Reason :
Describe the quality problem
Date of reporting : 5/21/2018 11:07:00 AM
History of the accident : -
Report type: Product Problem
Reporter Group : Health Centers
Survey Results
Corrective action taken : Notification/Relabeling
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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