The Recall Desk

FDA (Devices) recall action 95958

GE Medical Systems, LLC recalled 3 products on 2025-01-15

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2025-01-15
Critical
0
Units
454

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2025-01-15

    GE Optima XR Mobile Radiographic System Column Safety Mechanism Defect

    GE Healthcare Optima XR mobile X-ray systems with column replacements may have missing bolts in the Column Safety mechanism. If bolts are missing and the internal cable fails, the arm could drop, creating a risk of injury to staff or patients.

    Product
    GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-01-15

    Medical radiographic system arm drop hazard due to missing safety bolts

    GE Healthcare Optima XR240amx systems with column replacement may have missing bolts in the Column Safety mechanism. If these bolts are missing and the counterpoise cable fails, the X-ray arm could drop.

    Product
    GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-01-15

    Mobile Radiographic System Arm May Drop Due to Missing Safety Bolts

    GE Healthcare Optima XR200amx mobile radiographic systems may have missing bolts in the Column Safety mechanism, which could allow the X-ray arm to drop if an internal cable fails.

    Product
    GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
    Category
    Distribution
    0 states