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U.S. Department of Health and Human Services

Class 2 Device Recall Positron Emission Tomography and Computed Tomography System, Model: uMI 550

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 Class 2 Device Recall Positron Emission Tomography and Computed Tomography System, Model: uMI 550see related information
Date Initiated by FirmMay 30, 2022
Date PostedOctober 13, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0087-2023
Recall Event ID 90888
510(K)NumberK182237 K193241 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductPositron Emission Tomography and Computed Tomography System, Model: uMI 550
Code Information 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
Recalling Firm/
Manufacturer		 Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 5/30/22, advisory notices were emailed to customers who were asked to do the following: If the connection is not stable, perform a system reboot immediately and observe if the ECG and respiratory signals are restored. 2. If a system reboot cannot restore the wireless connection, use a third-party trigger device that supports 50ohm BNC interface and TTL output pulse with 100ms width, and connect to the system's external trigger port on the front cover. The port can be located according to Section 3.4.7 of the System Operator Manual. a) Make sure ECG and respiratory square pulse signals are displayed on the console monitor; b) Perform gated reconstruction based on the ECG and respiratory trigger pulses. 3. For further questions, please contact your recalling firm service engineer or call the Customer Contact Center's 24-hour hotline at (855) 221-1552 (toll-free) or (832) 699-2799 (direct). 4. Notify all your internal users of the PET/CT system, using this letter. 5. Complete and return the Receipt of Advisory Notification. The recalling firm will perform a design change and update the firmware of the wireless VSM module to resolve this issue. This design change is scheduled to be released for the on-site upgrade in August 2022.
Quantity in Commerce32
DistributionDistribution to US states of TX, WI, CA, and MI
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KPS
510(K)s with Product Code = KPS
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