Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce
FDA device recall Z-2705-2020 · posted 2020-07-27 · Open, Classified
Recall details
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Reason for recall
- The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
- Action taken
- A Customer Notification Letter was sent to the affected consignees on 06/20/2020 via email. United Imaging will replace the mylar strip with an improved one on the affected products via on-site update. On 8/30/2024, a correction notice was sent identifying an additional serial number.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 3
- Distribution
- US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
- Date initiated
- 2020-06-20
- Date posted
- 2020-07-27
- Location
- Shanghai, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| uCT 530, uCT 550 (K181414) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-08-14 |