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Recall Observatory FDA recall evidence

Device product

Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

Z-0445-2021

August 05, 2020

Class II

Product summary

Firm
Shanghai United Imaging Healthcare Co., Ltd.
Event
Event 86269
Status
Ongoing
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-0445-2021

Official wording

Reason: A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

Code information: Serial Numbers: 3000162, 300163, 300174, 300176

Distribution pattern: US Nationwide distribution including in the state of TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.