Shanghai United Imaging Healthcare recalls

Shanghai United Imaging Healthcare has 21 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 19 Apr 2023. 13 are still ongoing.

Total recalls21since 2020

Last 12 months0reported

Class I00% of total

Ongoing13latest 19 Apr 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 21 100%Class III 0 0%

Why shanghai united imaging healthcare is recalled

Product types

By year

202315%
2022210%
2021314%
20201571%

Ongoing shanghai united imaging healthcare recalls

13 active

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
18 Nov 2020Device	CLASS II	Computed Tomography X-Ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	Nationwide
18 Nov 2020Device	CLASS II	Computed Tomography X-Ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	Nationwide

All shanghai united imaging healthcare recalls, newest first

21 total

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
10 Mar 2021Device	CLASS II	Digitial Medica X-ray Imagining System recalled	Shanghai United Imaging Healthcare	Other	Nationwide
18 Nov 2020Device	CLASS II	Computed Tomography X-Ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	Nationwide
18 Nov 2020Device	CLASS II	Computed Tomography X-Ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	Nationwide
18 Nov 2020Device	CLASS II	Computed Tomography X-Ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	Nationwide
18 Nov 2020Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Other	Nationwide
26 Aug 2020Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
19 Aug 2020Device	CLASS II	uMI 550 PET/CT Diagnostic Imaging System recalled	Shanghai United Imaging Healthcare	Foreign Material	Nationwide
19 Aug 2020Device	CLASS II	uEXPLORER PET/CT Diagnostic Imaging System recalled	Shanghai United Imaging Healthcare	Foreign Material	Nationwide
5 Aug 2020Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Foreign Material	Nationwide
5 Aug 2020Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Foreign Material	Nationwide
5 Aug 2020Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Foreign Material	Nationwide
29 Jul 2020Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	TX
15 Jul 2020Device	CLASS II	uCT 760 System, Computed Tomography X-ray System recalled	Shanghai United Imaging Healthcare	Other	TX
15 Jul 2020Device	CLASS II	uDR 596i Digital Medical X-Ray Imaging System recalled	Shanghai United Imaging Healthcare	Other	Nationwide
8 Jul 2020Device	CLASS II	uCT 530 Computed Tomography X-Ray System recalled	Shanghai United Imaging Healthcare	Other	TX
22 Apr 2020Device	CLASS II	Positron Emission Tomograpy and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.