GE Medical Optima XR240amx X-Ray System Recalled in Canada Over Column Assembly Issue

Health Canada has issued a Type II medical device recall for the Optima XR240amx X-Ray System, manufactured by GE Medical Systems, LLC. The recall, identified under reference number RA-82245, affects specific units of this mobile X-ray system due to a column assembly performance issue. The alert is directed at healthcare facilities and professionals using affected units in clinical settings.

What Products Are Being Recalled?

The recall covers the Optima XR240amx X-Ray System, a mobile radiology device used in healthcare environments. Two specific lot/serial numbers are affected under model/catalogue number 5737545:

• Lot/Serial Number: 905522AMX240 — Model: 5737545
• Lot/Serial Number: 519941XR240A — Model: 5737545

The recall was initiated by GE Medical Systems, LLC, headquartered at 3000 North Grandview Blvd., Waukesha, Wisconsin, United States, and published by Health Canada on June 23, 2026. The official recall date is June 15, 2026.

Why Was This Recall Issued?

The recall was triggered by a medical device performance issue related to the mobile X-ray column assembly on certain Optima XR200/220/240amx systems. A faulty or compromised column assembly in a mobile X-ray unit can affect the stability, movement, and positioning of the X-ray arm, potentially leading to inaccurate imaging or mechanical failure during use. Such failures in a clinical radiology setting can disrupt patient care and pose risk to both patients and healthcare workers in proximity to the device.

This is classified as a Type II recall, meaning the use of the affected product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Who Is Affected?

This recall is directed at healthcare professionals and institutions operating the Optima XR240amx X-Ray System in Canada. Affected parties include:

• Hospitals and diagnostic imaging centres using the recalled lot/serial numbers
• Radiology departments and mobile X-ray unit operators
• Healthcare procurement and biomedical engineering teams responsible for medical device management

End consumers and general members of the public are not directly affected, as this is a professional-use medical device.

What Should You Do?

If you are a healthcare provider or facility manager overseeing the use of an Optima XR240amx X-Ray System, Health Canada recommends the following steps:

• Check your device records against the affected lot/serial numbers: 905522AMX240 and 519941XR240A under model 5737545.
• If your unit is affected, contact GE Medical Systems, LLC directly for further guidance and instructions.
• Do not continue using the device if the column assembly shows signs of instability or malfunction until the manufacturer has been consulted.
• Document the recall and take appropriate corrective action as per your facility’s medical device management protocols.
• Report any adverse events or device malfunctions to Health Canada through the official safety concern reporting channel.

For manufacturer contact, reach GE Medical Systems, LLC at their headquarters: 3000 North Grandview Blvd., Waukesha, Wisconsin, United States, 53188.

Official Statement

Health Canada has classified this as a health product recall under the category of Medical Devices — Radiology. The recall is listed under identification number RA-82245 and was last updated on June 23, 2026. Health Canada advises all affected parties to contact the manufacturer if they require additional information. Healthcare institutions are encouraged to subscribe to Health Canada recall notifications at the official recalls and safety alerts portal to stay informed of future updates.