Reported Oct 6, 2021 · Ongoing
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the…
Shanghai United Imaging Healthcare Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shanghai United Imaging Healthcare Co., Ltd. · No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, N/A · N/A
Is this the product you have?
- uMI 550 System - Product Usageintended 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
- Lot codes and dates
22 of 22 products
Products covered by this recall Model / number Barcodes Product as published 20001706971576832026/ 01 06971576832026 240 88000057 21 20002306971576832026/ 01 06971576832026 240 88000057 21 20002406971576832026/ 01 06971576832026 240 88000057 21 20003606971576832026/ 01 06971576832026 240 88000057 21 20004506971576832026/ 01 06971576832026 240 88000057 21 20004706971576832057/ 01 06971576832057 240 88000057 21 23000206971576832057/ 01 06971576832057 240 88000057 21 23000306971576832057/ 01 06971576832057 240 88000057 21 23000406971576832057/ 01 06971576832057 240 88000057 21 20005906971576832057/ 01 06971576832057 240 88000057 21 23000506971576832057/ 01 06971576832057 240 88000057 21 23000606971576832057/ 01 06971576832057 240 88000057 21 23000706971576832057/ 01 06971576832057 240 88000057 21 23000806971576832057/ 01 06971576832057 240 88000057 21 23000906971576832057/ 01 06971576832057 240 88000057 21 23001006971576832057/ 01 06971576832057 240 88000057 21 23001106971576832057/ 01 06971576832057 240 88000057 21 23001206971576832057/ 01 06971576832057 240 88000057 21 23001306971576832057/ 01 06971576832057 240 88000057 21 23001406971576832057/ 01 06971576832057 240 88000057 21 - Amount recalled
- 23 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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