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U.S. Department of Health and Human Services

Class 2 Device Recall GE Medical Systems Revolution

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  Class 2 Device Recall GE Medical Systems Revolution see related information
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/
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
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.

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.