PET/CT imaging system loses vital signs data in strong Wi-Fi environments
Certain PET/CT imaging systems may lose vital sign monitoring due to Wi-Fi interference, potentially requiring patient rescans.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall where no illnesses or injuries have been reported. The hazard is theoretical and conditional on Wi-Fi environment exposure. However, the risk of diagnostic imaging failure in a medical device warrants High severity given the potential impact on diagnostic quality.
Plain-English summary
The wireless vital signs monitoring (VSM) module in the Shanghai United Imaging Healthcare uMI 550 PET/CT imaging system is subject to this recall. The system uses a wireless module to monitor ECG and respiratory signals during imaging procedures.
In environments with strong Wi-Fi signals, the wireless VSM module may experience interference that causes loss of ECG and respiratory signals. This signal loss can prevent proper gated reconstruction of the PET scan images, which may require the patient to undergo a repeat scan.
This recall affects 32 units distributed to facilities in Texas, Wisconsin, California, and Michigan.
The recalled product
- Product
- Positron Emission Tomography and Computed Tomography System, Model: uMI 550
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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