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Gus Iversen, Editor in Chief | July 22, 2026
GE HealthCare's Optima XR220amx
GE Medical Systems is recalling 38 Optima XR220amx mobile digital-ready radiographic systems after identifying a potential safety issue involving units that previously underwent a column replacement.
The FDA classified the action as a Class II recall on July 13. The recall, identified as Z-2727-2026, remains open.
According to the recall notice, GE HealthCare determined that functional testing of the column safety pawl may not have been performed after some column replacements. If the system's internal counterpoise cable later fails, the safety mechanism designed to prevent the X-ray tube arm and collimator from falling may not function as intended. The company said the arm could drop down the column track, creating a risk of patient injury during an exam.
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The FDA listed the recall's root cause as process control.
GE sent an Urgent Medical Device Correction letter to customers on June 5. While the company completes corrective actions, it said affected systems may remain in service if users perform a visual and functional check before every patient examination.
Customers are instructed to stop using the system and contact GE HealthCare Service immediately if they observe increased effort when moving the column vertically, changes in movement resistance, abnormal noises during vertical movement or other signs that the column is not moving smoothly. Facilities are also advised to notify all potential users of the safety notice, retain the notification for their records and return the manufacturer's acknowledgment form.
The recall affects Optima XR220amx mobile digital-ready radiographic systems with UDI-DI 00840682115261 and specified system identification numbers listed in the FDA enforcement report. The device is regulated as a mobile X-ray system under product code IZL and is cleared under 510(k) numbers K103476 and K142383.
The affected products were distributed throughout the United States and in Brazil, Canada, South Korea, Mexico, Saudi Arabia, Spain and the United Kingdom. No injuries were reported in the FDA recall notice.
