Date Initiated by Firm |
November 21, 2002 |
Date Posted |
February 12, 2003 |
Recall Status1 |
Terminated 3 on July 02, 2004 |
Recall Number |
Z-0157-03 |
Recall Event ID |
25531 |
510(K)Number |
K012389
|
Product Classification |
unknown device name - Product Code 90LMA
|
Product |
Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems
|
Code Information |
All serial numbers in distribution at the time of the recall. |
Recalling Firm/ Manufacturer |
General Electric Med Systems 3000 N Grandview Blvd Waukesha WI 53186
|
Manufacturer Reason for Recall |
The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.
|
FDA Determined Cause 2 |
Other |
Action |
Field modification instructions were issued on 11/21/02 to GE field engineers who placed the certification label on the equipment. |
Quantity in Commerce |
78 devices |
Distribution |
The product had been shipped to hospitals located nationwide in the United States.
|
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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.
|
510(K) Database |
510(K)s with Product Code = 90LMA and Original Applicant = GE MEDICAL SYSTEMS, INC.
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