Optima XR646 HD. X-Ray imaging system.

FDA device recall Z-1046-2025 · posted 2025-02-03 · Open, Classified

Recall details

Recalling firm

GE Medical Systems, LLC

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.

Action taken

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

Status

Open, Classified

Product code

KPR

Quantity affected

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,

Date initiated

2025-01-28

Date posted

2025-02-03

Location

Waukesha, WI

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