United Imaging uMI 550 PET/CT System Recalled for Incorrect CT Scan Delay Timer
Shanghai United Imaging Healthcare is recalling nine uMI 550 PET/CT systems because an incorrect CT scan delay timer may display, potentially exposing operators to unnecessary radiation.
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: The recall is classified as FDA Class II and involves a risk of unnecessary radiation exposure to operators, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling nine Positron Emission Tomography and Computed Tomography (PET/CT) Systems, Model uMI 550. The recall involves specific serial numbers: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, and 230004. These devices were distributed nationwide in the United States, including in Texas.
The recall is due to a potential issue where an incorrect CT scan delay timer may be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This display error could lead the operator to receive unnecessary exposure to radiation. The devices are 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 oncology, cardiology, and neurology.
Healthcare facilities and operators should contact Shanghai United Imaging Healthcare Co., Ltd. for instructions on how to resolve the issue. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning…
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Hazard
- Affected units
- 9
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 (9)
- Serial Numbers: 200017
- 200023
- 200024
- 200036
- 200045
- 200047
- 230002
- 230003
- 230004
Distribution
Part of a larger recall action
This product is one of 4 recalled by Shanghai United Imaging Healthcare Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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