CLASS II ONGOING Device recall · Reported 5 Aug 2020 · FDA Enforcement Report

Computed Tomography X-ray System recalled by Shanghai United Imaging

Shanghai United Imaging Healthcare is recalling Computed Tomography X-ray System, distributed nationwide in the US. The recall was initiated on 20 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSN 600229, 600230, 600232, 600271, 600282

Quantity recalled5 units

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-2703-2020
FDA event ID: 85868
Recalling firm: Shanghai United Imaging Healthcare, Shanghai, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jun 2020
FDA classified: 27 Jul 2020
Reported: 5 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

20 Jun 2020	Recall initiated by company
27 Jul 2020	Classified by FDA	+37 days
5 Aug 2020	Published in enforcement report	+9 days

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

Reason for recall

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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).

Where it was distributed

US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.

Nationwide California Indiana Texas

Questions about this recall

Why was it recalled?

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

Which lots are affected?

SN 600229, 600230, 600232, 600271, 600282

Where was it sold?

US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.

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.

Other products in this recall event

2 other products · FDA event 85868

This product is part of a recall event; the main page for the event is Computed Tomography X-ray System recalled by Shanghai United Imaging.

Reported	Class	Recall	Company	Reason	Where
5 Aug 2020	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Foreign Material	Nationwide
5 Aug 2020	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Foreign Material	Nationwide

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
18 May 2022Device	CLASS II	Digital Medical X-ray Imaging System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Labeling Errors	Nationwide
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

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16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide