Positron Emission Tomography and Computed Tomography recall
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Why was Positron Emission Tomography and Computed Tomography recalled?
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.
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?
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
- Product
- Positron Emission Tomography and Computed Tomography System, Model: uMI 550
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 32
- Distribution
- Distribution to US states of TX, WI, CA, and MI
- Recall date
- October 19, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)