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.
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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