| 2023-03-01 |
Class II
|
Ongoing |
Z-1353-2023 |
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI … |
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Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET ima… |
| 2022-05-30 |
Class II
|
Ongoing |
Z-0087-2023 |
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 |
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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 … |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2594-2021 |
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the … |
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The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. |
| 2021-08-02 |
Class II
|
Ongoing |
Z-2593-2021 |
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection… |
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The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. |
| 2021-01-25 |
Class II
|
Terminated |
Z-1160-2021 |
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended t… |
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There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient. |
| 2020-08-05 |
Class II
|
Ongoing |
Z-0448-2021 |
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usag… |
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A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This coul… |
| 2020-08-05 |
Class II
|
Ongoing |
Z-0447-2021 |
Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross… |
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A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This coul… |
| 2020-08-05 |
Class II
|
Ongoing |
Z-0446-2021 |
Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross… |
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A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This coul… |
| 2020-08-05 |
Class II
|
Ongoing |
Z-0445-2021 |
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross… |
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A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This coul… |
| 2020-07-16 |
Class II
|
Terminated |
Z-2800-2020 |
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare… |
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1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to a… |
| 2020-07-16 |
Class II
|
Terminated |
Z-2799-2020 |
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthca… |
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1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle sign… |
| 2020-06-20 |
Class II
|
Ongoing |
Z-2705-2020 |
Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produc… |
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The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. |
| 2020-06-20 |
Class II
|
Ongoing |
Z-2704-2020 |
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produc… |
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The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. |
| 2020-06-20 |
Class II
|
Ongoing |
Z-2703-2020 |
Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - Product Usage: intended to produc… |
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The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge. |
| 2020-05-23 |
Class II
|
Ongoing |
Z-2641-2020 |
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ra… |
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Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ri… |
| 2020-05-08 |
Class II
|
Terminated |
Z-2522-2020 |
uCT 760 System, Computed Tomography X-ray System |
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Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and inte… |
| 2020-05-08 |
Class II
|
Ongoing |
Z-2472-2020 |
uCT 530 Computed Tomography X-Ray System |
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Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ri… |
| 2020-03-26 |
Class II
|
Terminated |
Z-2819-2020 |
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: … |
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In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when usi… |
| 2020-02-27 |
Class II
|
Terminated |
Z-2521-2020 |
uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or techni… |
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Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position… |