CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report

Positron Emission Tomograpy and Computed Tomography System recalled

Shanghai United Imaging Healthcare is recalling Positron Emission Tomograpy and Computed Tomography System, distributed nationwide in the US. The recall was initiated on 26 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 200017 and 200023

Quantity recalled2 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-1708-2020
FDA event ID: 85340
Recalling firm: Shanghai United Imaging Healthcare, Shanghai
Classification: Class II
Status: Terminated
Recall initiated: 26 Aug 2019
FDA classified: 15 Apr 2020
Reported: 22 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

26 Aug 2019	Recall initiated by company
15 Apr 2020	Classified by FDA	+233 days
22 Apr 2020	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

Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is 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

US Nationwide distribution in the state TX.

Nationwide Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: 200017 and 200023

Where was it sold?

US Nationwide distribution in the state 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
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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