Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Summary
The FDA issued a Class II for Positron Emission Tomography and Computed Tomography System, Model: uMI 550 by Shanghai United Imaging Healthcare Co., Ltd.. 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 si.
Details
Source
Device Recall
External ID
Z-0087-2023
Action Date
2022-10-19
Status
Ongoing
Category
device
Product Description
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Lot/Code Info: 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
Quantity Affected: 32
Reason for Recall
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.
Distribution
Distribution to US states of TX, WI, CA, and MI
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-30
Company
Shanghai, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Shanghai United Imaging Healthcare Co., Ltd. has 48 FDA actions in our database, including 5 recalls and 43 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Shanghai United Imaging Healthcare Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Shanghai United Imaging Healthcare Co., Ltd. have FDA actions?
Shanghai United Imaging Healthcare Co., Ltd. has 48 FDA actions in our database, including 5 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0087-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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