ProductGuru Recalls

Official recall record

GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4)

US FDA — Medical Devices · 2024-11-25 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Alert date
2024-11-25
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
840682122351
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 performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

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 2026-05-31.

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