uMI 550 PET/CT Diagnostic Imaging System - Product recall
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in…
Why was uMI 550 PET/CT Diagnostic Imaging System - Product recalled?
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)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial No.s 200017, 200023, 200024 and 200036.
- Product
- uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in…
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution including in the state of Texas.
- Recall date
- August 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)