CLASS II ONGOING Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

uEXPLORER PET/CT System recalled by Shanghai United Imaging

Shanghai United Imaging Healthcare is recalling uEXPLORER PET/CT System, distributed nationwide in the US. The recall was initiated on 2 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002

Quantity recalled1 system

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-2594-2021
FDA event ID: 88521
Recalling firm: Shanghai United Imaging Healthcare, Shanghai, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 2 Aug 2021
FDA classified: 29 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Aug 2021	Recall initiated by company
29 Sep 2021	Classified by FDA	+58 days
6 Oct 2021	Published in enforcement report	+7 days

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

Reason for recall

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

Product as listed by the FDA

uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Where it was distributed

U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.

Nationwide California Illinois Indiana Texas Wisconsin

Questions about this recall

Why was it recalled?

The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.

Which lots are affected?

Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002

Where was it sold?

U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.

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

1 other product · FDA event 88521

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021	CLASS II	uMI 550 System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Other	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
10 Mar 2021Device	CLASS II	Digitial Medica X-ray Imagining System recalled	Shanghai United Imaging Healthcare	Other	Nationwide

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