Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Summary
The FDA issued a Class II for Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h by Shanghai United Imaging Healthcare Co., Ltd.. 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 b.
Details
Source
Device Recall
External ID
Z-1075-2022
Action Date
2022-05-18
Status
Terminated
Category
device
Product Description
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Lot/Code Info: DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
Quantity Affected: 4
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.
Distribution
US Nationwide distribution in the state of TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2019-07-30
Company
Shanghai, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 140 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Shanghai United Imaging Healthcare Co., Ltd. has 48 FDA actions in our database, including 5 recalls and 43 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Shanghai United Imaging Healthcare Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Shanghai United Imaging Healthcare Co., Ltd. have FDA actions?
Shanghai United Imaging Healthcare Co., Ltd. has 48 FDA actions in our database, including 5 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1075-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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