Medical device specifications
Recall Date : 10/2/2018
Recall Class : 2
Common Device  Name: Crt Implantable Pacemaker
Brand Device Name : -
Manufacturing Country : UNITED STATES
Model : (VALITUDE X4 (U128) and VALITUDE(U125
Serial No. : -
Importer / manufacturer company : Jahan Gostaresh Tejarat Co.
Recall Reason :
Describe the quality problem
Date of reporting : 8/13/2018
History of the accident : -
Report type: Product Problem
Reporter Group :
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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