Official recall record
Optima XR240amx, Mobile Digital Radiographic System
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-06-05
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00840682122351
- Brand on record
- GE Medical Systems, LLC
What the authority reported
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. 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. This could result in patient injury during an exam.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
Other recalls from this brand
- 2026-06-05 · US FDA — Medical Devices
Optima XR220amx, Mobile Digital-Ready Radiographic System - 2026-06-05 · US FDA — Medical Devices
Optima XR200amx, Mobile Digital-Ready Radiographic System - 2026-05-01 · US FDA — Medical Devices
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