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U.S. Department of Health and Human Services

Class 2 Device Recall OEC 9900 Elite

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 Class 2 Device Recall OEC 9900 Elitesee related information
Date Initiated by FirmJuly 02, 2025
Date PostedAugust 22, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2342-2025
Recall Event ID 97454
510(K)NumberK073543 K082781 K120613 K122234 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductGE HealthCare OEC 9900 Elite C-arm Systems.
Code Information GTIN: 00840682114349
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3011
Manufacturer Reason
for Recall		GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionGE HealthCare will send a customer letter providing safety instructions as an immediate mitigation, to communicate the risk of additional radiation and that the equipment should only be used by personnel properly trained and authorized in the use of ionizing radiation. A user should observe proper safety practices during equipment operation as required by the operator manual. GE HealthCare will correct all affected OEC 9800 and OEC 9900 Elite systems (28 units) by visually inspecting for the presence of lead shield tape on the collimator cover and replacing the collimator cover if it is found non-compliant, at no cost to the customer.
DistributionUS Nationwide distribution.
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 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) 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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