|
Class 2 Device Recall ProTimePROTIMEPRO |
|
Date Initiated by Firm |
November 19, 2007 |
Date Posted |
January 25, 2008 |
Recall Status1 |
Terminated 3 on August 12, 2008 |
Recall Number |
Z-0546-2008 |
Recall Event ID |
45809 |
510(K)Number |
K010599
|
Product Classification |
Microcoagulation System: - Product Code GJS
|
Product |
ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Technidyne Corporation (ITC), Piscataway, NJ 08854 |
Code Information |
All instruments with Serial Number V56560 or lower. |
Recalling Firm/ Manufacturer |
International Technidyne Corporation 20 Corporate Pl S Piscataway NJ 08854-6144
|
For Additional Information Contact |
732-548-5700
|
Manufacturer Reason for Recall |
An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages.
|
FDA Determined Cause 2 |
Device Design |
Action |
ITC sent to distributors, self test users and health care professionals on 11/19/07, an Urgent Medical Device Recall Letter requesting return of the devices. |
Quantity in Commerce |
3,482 units |
Distribution |
Worldwide-USA and countries of China, Taiwan, Greece, Ireland, Chile, Finland, Italy, Spain, Norway, Germany, Switzerland., Singapore, Korea, Indonesia, Lichtenstein, Israel, Saudi Arabia, Latvia, Kuwait, and Slovenia. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = GJS and Original Applicant = INTERNATIONAL TECHNIDYNE CORP.
|
|
|
|