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Discovery recallZ-1043-2025 · GE Medical Systems, LLC · initiated Jan 28, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Radiation Control for Health and Safety Act

What the company is doing

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.

Recall details

Recall number
Z-1043-2025
Status
Open, Classified
Initiated by the company
Jan 28, 2025
Posted by the FDA
Feb 3, 2025
Recalling firm
GE Medical Systems, LLC
Quantity
3149 (1697 US; 1452 OUS)
Product code
KPR
FDA submissions
K231892
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, 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.

Product description

Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.

Code information (models, lots, serial numbers)

GTINs: 00840682138598, 00195278840226, 00840682136709)

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K231892 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96208).

Sources and updates

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