Recall Z-1044-2025 ยท KPR System, X-Ray, Stationary
GE Medical Systems, LLC
Discovery XR656HD. X-Ray imaging system.
| Date | Feb 3, 2025 (initiated Jan 28, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Firm 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 terminatio |
| Quantity | 3149 (1697 US; 1452 OUS) |
| Distribution | Worldwide 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191699 | Discovery XR656 HD with VolumeRad Ge Hualun Medical Systems Co. , Ltd., Jul 24, 2019 |