CLASS II Device recall · Reported 18 May 2022 · FDA Enforcement Report

Digital Medical X-ray Imaging System recalled by Shanghai United Imaging

Shanghai United Imaging Healthcare is recalling Digital Medical X-ray Imaging System, distributed nationwide in the US. The recall was initiated on 30 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015

Quantity recalled4

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1075-2022
FDA event ID: 90104
Recalling firm: Shanghai United Imaging Healthcare, Shanghai, N/A
Classification: Class II
Status: Terminated
Recall initiated: 30 Jul 2019
FDA classified: 12 May 2022
Reported: 18 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Imaging Equipment

Timeline

30 Jul 2019	Recall initiated by company
12 May 2022	Classified by FDA	+1017 days
18 May 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

Where it was distributed

US Nationwide distribution in the state of TX.

Nationwide Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015

Where was it sold?

US Nationwide distribution in the state of TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Shanghai United Imaging Healthcare

All 21

Reported	Class	Recall	Company	Reason	Where
19 Apr 2023Device	CLASS II	Ltd Positron Emission Tomography (PET) and Computed Tomography (CT) recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
19 Oct 2022Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	4 states
6 Oct 2021Device	CLASS II	uMI 550 System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	Nationwide
6 Oct 2021Device	CLASS II	uEXPLORER PET/CT System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	Nationwide
10 Mar 2021Device	CLASS II	Digitial Medica X-ray Imagining System recalled	Shanghai United Imaging Healthcare	Other	Nationwide

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