uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the
Summary
The FDA issued a Class II for uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified he by Shanghai United Imaging Healthcare Co., Ltd.. Reason: The EXAM acquisition workflow could occasionally freeze after canceling the PET scan..
Details
Source
Device Recall
External ID
Z-2594-2021
Action Date
2021-10-06
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002
Quantity Affected: 1 system
Reason for Recall
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Distribution
U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-02
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 201 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-2594-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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