---
title: "Positron Emission Tomography and Computed Tomography System, Model: uMI 550 — FDA record Z-0087-2023 | Is It on Recall"
description: "The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss"
url: https://isitonrecall.com/recall/fda-device-z-0087-2023-positron-emission-tomography-and-computed-tomography-system-model-umi-550/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Positron Emission Tomography and Computed Tomography System, Model: uMI 550 — FDA record Z-0087-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 30, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Positron Emission Tomography and Computed Tomography System, Model: uMI 550
- **Reason**: The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.
- **Classification**: Class II
- **Recalling firm**: Shanghai United Imaging Healthcare Co., Ltd.
- **Quantity**: 32
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0087-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0087-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI/Serial Numbers: 06971576832026/230002, 230003, 230004, 230005, 230006, 230007, 230008, 230009, 230010, 230011, 230012, 230013, 230014, 230015, 230016, 230017, 230019, 230020, 230021, 230022, 230023, 230024, 230025, 230026, 230027, 230028, 230029, 230030, 230031, 230032, 230033, 232001 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distribution to US states of TX, WI, CA, and MI

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Oct 19, 2022
- **Recall initiation date**: May 30, 2022
- **Center classification date**: Oct 13, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0087-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Shanghai United Imaging Healthcare Co., Ltd. records](https://isitonrecall.com/brand/shanghai-united-imaging-healthcare-co-ltd/)