uEXPLORER PET/CT System - Product Usage: intended to be recall
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization…
Why was uEXPLORER PET/CT System - Product Usage: intended to be recalled?
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002
- Product
- uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization…
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 1 system
- Distribution
- U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
- Recall date
- October 6, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)