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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9800

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 Class 2 Device Recall OEC 9800see related information
Date Initiated by FirmJuly 22, 2016
Create DateAugust 23, 2016
Recall Status1 Terminated 3 on December 19, 2016
Recall NumberZ-2629-2016
Recall Event ID 74808
510(K)NumberK021049 K022069 K111551 K974355 K993687 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductOEC 9800, fluoroscopic x-ray system
Code Information monitor part numbers: 5448359-01, 5459219-01, or 5475662-03:89-3853, 82-1593, 8S-1935, 89-3356, 89-1323, 8S-2885, 82-0700, 8S-1708, 82-0420, 82-1998, 8S-2027, 82-7101-MH, 8S-2670, P6-0375-L, 8S-1614, 89-0846, 82-0576, 82-3256, 8S-2202, 89-0711,89-1927, 89-1453, 82-1504, 82-0794, 82-3494, 8S-3125, 8S-1845-RC, 89-3725, 8S-1592, 89-3129,82-1182, 82-0986, 8S-0199, 8S-3613, 82-3748, 82-2335, 8S-2889, 82-0596, 89-3020, 82-1515, 8S-0645, 8S-3614, 82-3925, 89-0416, 89-1363, 82-3258, 8S-0347
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 N Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information ContactDeena M. Pease,
847-852-3433
Manufacturer Reason
for Recall		A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.
FDA Determined
Cause 2		Software design (manufacturing process)
ActionOn July 22, 2016 GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to customers via mail to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter was sent to 3 titles at each facility affected: 1.) Facility Administrator, 2.) Director/Manager of Radiology and Radiologists, 3.) Radiology Department. Consignees instructured that local GE Healthcare Field Engineer will contact them to coordinate replacement of the affected monitor(s), and will ensure that system meets specifications.
Quantity in Commerce47 total
DistributionDistribution US nationwide and Korea.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
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