Recall Z-1075-2022— Shanghai United Imaging Healthcare Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Shanghai United Imaging Healthcare Co., Ltd., initiated 2019-07-30, terminated 2022-05-17. It names one FDA 510(k) clearance: K181413. Product: Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h. Reason: X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure..
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-30
- Terminated
- 2022-05-17
- Firm location
- Shanghai, N/A, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Reason for recall
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.