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U.S. Department of Health and Human Services

Class 2 Device Recall Definium Pace Select

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 Class 2 Device Recall Definium Pace Selectsee related information
Date Initiated by FirmJanuary 28, 2025
Date PostedFebruary 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1043-2025
Recall Event ID 96208
510(K)NumberK231892 
Product Classification System, x-ray, stationary - Product Code KPR
ProductDefinium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Code Information GTINs: 00840682138598, 00195278840226, 00840682136709)
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactStephanie Cass
262-544-3011
Manufacturer Reason
for Recall		The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionFirm sent an "IMPORTANT ELECTRONIC PRODUCT RADIATION WARNING" email/letter to its consignees. The email/letter described the product, the problem and the actions to be taken. The consignees were instructed to do the following: You can continue to use the device as intended for clinical use, by following the instructions below: 1.If you perform an exposure and observe an on-screen message that the AEC termination limit has been reached, please acknowledge the message. 2.Take any relevant actions to adjust techniques or patient positioning for the next exposure to avoid reaching the termination limit for that exposure, if appropriate. Please ensure that all potential users in your facility are made aware of this notification and the recommended actions. Please retain this document for your records. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce3149 (1697 US; 1452 OUS)
DistributionWorldwide Distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries to: Canada, Chile, China, Colombia, Coast Rica, Croatia, Cyprus, Czech Republic, Czechia, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iraq, Ireland, Italy, Jamaica, Japan, Jordan, Kenya, Korea (Republic of) Kuwait, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
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 = KPR
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