Z-2703-2020 Class II Ongoing
FDA device recall Z-2703-2020 was initiated by Shanghai United Imaging Healthcare Co., Ltd. on June 20, 2020 and is designated Class II. Reason for recall: The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. The recall status is ongoing. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- June 20, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - 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).
Reason for Recall
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Distribution Pattern
US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
Code Information
SN 600229, 600230, 600232, 600271, 600282