The Recall Desk

Manufacturer

GE Hangwei Medical Systems, Co. LTD

2 recalls in our database name GE Hangwei Medical Systems, Co. LTD as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2023-12-20

Of the 2 recalls from GE Hangwei Medical Systems, Co. LTD we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-0553-2024·2023-12-20

    X-ray system overhead suspension components may fall due to incorrect bolt torque

    GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.

    Product
    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2024·2023-12-20

    GE Definium Tempo X-Ray System Bolts May Loosen and Fall

    Incorrect bolt torque on GE Definium Tempo X-ray systems may cause the overhead tube suspension assembly to fall. No injuries have been reported, but GE recommends immediate inspection of affected systems.

    Product
    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD sy
    Category
    Medical Device
    Distribution
    Distributed nationwide