Medical device specifications
Recall Date : 8/31/2020
Recall Class : 3
Common Device  Name: Soft tissue Biopsy Needles
Brand Device Name :
Producer company : GTA S.R.L . - Societa Unipersonale
Manufacturing Country :
Model :
Serial No. : LP0076/16
Importer / manufacturer company : Payam Teb Hayat
Recall Reason :
Describe the quality problem
Date of reporting : 11/5/2019
History of the accident : -
Report type: Product Problem
Reporter Group : Health Centers
Survey Results
Corrective action taken : Replace/Notification
Recall Status : Open
Description : سوزن بیوپسی نیمه اتوماتیک با لات نامبر: LP0076/16 مشکلاتی نظیر شکتگی سوزن و ... وجود دارد، اعلام گردد.

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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