Recall Z-2800-2020— Shanghai United Imaging Healthcare Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Shanghai United Imaging Healthcare Co., Ltd., initiated 2020-07-16, terminated 2022-07-07. It names one FDA 510(k) clearance: K182237. Product: uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is 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, but not limit to, oncology, cardiology and neurology.. Reason: 1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions (N/A for Serial No. 200036).
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-16
- Terminated
- 2022-07-07
- Firm location
- Shanghai, N/A, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is 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, but not limit to, oncology, cardiology and neurology.
Reason for recall
1) Service function problem may cause false marking of a bad channel resulting in ring artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions (N/A for Serial No. 200036)
Data sourced from openFDA. This site is unofficial and independent of the FDA.