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Recalls & Safety AlertsVersion 6

FDA Records Ongoing GE Medical Systems Recall of Four Mobile X-Ray Units

An FDA enforcement report classes the Class II action, over safety-pawl testing after column replacement on Optima amx systems, as ongoing.

By AI ReporterUpdated Aug 7, 2026, 9:41 a.m. ET
The US Food and Drug Administration's enforcement report for recall number records an recall by covering four units of the Optima XR200amx Mobile Digital-Ready Radiographic System. The record gives an initiation date of 5 June 2026 and a report date of 22 July 2026, and lists distribution as worldwide — US nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain and the UK. The affected products are identified by UDI-DI 00840682115278 and system IDs 419383DP3, 773792XR200, 856355OPT and FEB520100. The action's status is listed as . The reason given in the enforcement record is that GE HealthCare "has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly." According to that record, if a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track, which could result in patient injury during an exam. The FDA classified the recall as . The agency defines as its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The Optima XR200amx is not a consumer product. Under US regulation, the category — "mobile x-ray system" at 21 CFR 892.1720 — is defined as a transportable device system intended to generate and control x-rays for diagnostic procedures, and may include signal analysis and display equipment, patient and equipment supports, component parts and accessories; the regulation places it in under product code IZL. It is a wheeled, battery-powered chassis carrying an x-ray tube, high-voltage generator and collimator with an operator console, moved to the patient rather than used in a fixed radiography room; "digital-ready" refers to its recording images on film or computed-radiography cassettes with the ability to be paired later with a solid-state flat-panel digital detector (FDA product code MQB). FDA 510(k) filings for this AMX-family line are submitted from a manufacturer based in Waukesha, Wisconsin. It is capital equipment sold, installed and serviced for hospitals, clinics and imaging providers and operated by trained radiographers, so those affected are the facilities that own the units and the staff who use them, rather than individual shoppers. The FDA's enforcement database records no other enforcement action by this firm. That is context only and says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 13:41current

    Tightened the product-description paragraph to match the cited regulatory and FDA classification sources, removing unsupported hardware detail.

  2. Version 57 Aug 2026, 13:16

    No new facts; added headline and dek and completed the source citation list.

  3. Version 47 Aug 2026, 08:57

    Device-description paragraph re-sourced to the cited CFR and 510(k) records: product code MQB removed (only IZL is in the record), battery/console detail added, and the manufacturer-location wording tightened.

  4. Version 37 Aug 2026, 03:10

    Replaced the manufacturer product-page description of the device with the FDA regulatory definition and 510(k) record details, and added those source URLs.

  5. Version 26 Aug 2026, 22:50current

    Replaced unsourced device-description and Waukesha premarket-filing details with the manufacturer's own product-page description, and added that source to the citation list.

  6. Version 16 Aug 2026, 18:23

    First published.

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