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Open, Classified

Discovery XR656HD. X-Ray imaging system.

FDA Recall Z-1044-2025 · Posted 2025-02-03

Recall StatusOpen, Classified
Product CodeKPR
Date Initiated2025-01-28
Product Quantity3149 (1697 US; 1452 OUS)

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.

Firm 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 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

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, 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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