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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Discovery IQ

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 Class 2 Device Recall GE Healthcare Discovery IQsee related information
Date Initiated by FirmMay 19, 2017
Create DateJune 12, 2017
Recall Status1 Terminated 3 on July 29, 2018
Recall NumberZ-2192-2017
Recall Event ID 77377
510(K)NumberK141477 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductGE Healthcare Discovery IQ X-ray system
Code Information n/a
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
FDA Determined
Cause 2		Software design
ActionGE Healthcare proposed action to bring defect into compliance : 1. Inform users of the potential for this issue to occur and instruct users as to the actions to take in the event of an Emergency Stop actuation during prep-delay. 2. Provide an update to product labeling for users that includes this information. GE Healthcare will include the updated product labeling with all current production systems. 3. Make modifications during the next scheduled product update to prevent this "race" condition from occurring in newly produced systems. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. 3.You complete this recall by September 1, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator. For further questions, please call (262) 513-4122.
Quantity in Commerce10,884
DistributionWorldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.
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 = KPS
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