Date Initiated by Firm | April 14, 2009 |
Date Posted | July 07, 2009 |
Recall Status1 |
Terminated 3 on September 21, 2012 |
Recall Number | Z-1652-2009 |
Recall Event ID |
52430 |
510(K)Number | K071806 |
Product Classification |
Computed Tomography X-Ray System - Product Code JAK
|
Product | Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less. |
Code Information |
The recalled ECLOS system units are identified with the following Code Numbers: E1014, E5003 through E5005 |
Recalling Firm/ Manufacturer |
Hitachi Medical Systems America Inc 1959 Summit Commerce Park Twinsburg OH 44087
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For Additional Information Contact | 330-425-1313 Ext. 3720 |
Manufacturer Reason for Recall | Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to be displayed with the wrong scale factor rendering anatomical measurements incorrect. |
FDA Determined Cause 2 | Software design |
Action | HMSA issued an URGENT - DEVICE CORRECTION notification to their customers on 4/14/2009. The notification describes the potential software error and the condition under which these image distortions can occur. The notification goes on to provide the customer with a work-around procedure which they can use to avoid encountering this issue with their current software configuration(s). The letter states that the firm will be installing updated software on all affected systems beginning in June, 2009, and that a Hitachi Service Rep. will be contacting each customer and making arrangements to come out and install a software upgrade on the affected system(s) at no cost to the customer. Lastly, the letter provides a telephone # to the firm's Applications Helpline: 1-877-228-2777, which the customer can use to obtain additional information, if desired. |
Quantity in Commerce | 4 units |
Distribution | Nationwide distribution, including Puerto Rico (PR). |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAK
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