FDAFDA · Food and drugs·Recall number Z-2704-2020
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).
Published August 5, 2020 · Recall initiated: June 20, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Distributor
- US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
- Lot
- SN 300162, 300163, 300174, 300176
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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