CLASS II ONGOING Device recall · Reported 6 Oct 2021 · FDA Enforcement Report
uMI 550 System recalled by Shanghai United Imaging
Shanghai United Imaging Healthcare is recalling uMI 550 System, distributed nationwide in the US. The recall was initiated on 2 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2593-2021
- FDA event ID
- 88521
- Recalling firm
- Shanghai United Imaging Healthcare, Shanghai, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Aug 2021
- FDA classified
- 29 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Aug 2021 | Recall initiated by company | |
| 29 Sep 2021 | Classified by FDA | +58 days |
| 6 Oct 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Product as listed by the FDA
uMI 550 System - Product Usage: 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.
Where it was distributed
U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
Questions about this recall
Why was it recalled?
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Which lots are affected?
Model: 88000057 GTIN/UDI Codes: 06971576832026 / 01 06971576832026 240 88000057 21 200017 06971576832026 / 01 06971576832026 240 88000057 21 200023 06971576832026 / 01 06971576832026 240 88000057 21 200024 06971576832026 / 01 06971576832026 240 88000057 21 200036 06971576832026 / 01 06971576832026 240 88000057 21 200045 06971576832026 / 01 06971576832026 240 88000057 21 200047 06971576832057 / 01 06971576832057 240 88000057 21 230002 06971576832057 / 01 06971576832057 240 88000057 21 230003 06971576832057 / 01 06971576832057 240 88000057 21 230004 06971576832057 / 01 06971576832057 240 88000057 21 200059 06971576832057 / 01 06971576832057 240 88000057 21 230005 06971576832057 / 01 06971576832057 240 88000057 21 230006 06971576832057 / 01 06971576832057 240 88000057 21 230007 06971576832057 / 01 06971576832057 240 88000057 21 230008 06971576832057 / 01 06971576832057 240 88000057 21 230009 06971576832057 / 01 06971576832057 240 88000057 21 230010 06971576832057 / 01 06971576832057 240 88000057 21 230011 06971576832057 / 01 06971576832057 240 88000057 21 230012 06971576832057 / 01 06971576832057 240 88000057 21 230013 06971576832057 / 01 06971576832057 240 88000057 21 230014 06971576832057 / 01 06971576832057 240 88000057 21 230015 06971576832057 / 01 06971576832057 240 88000057 21 230016 06971576832057 / 01 06971576832057 240 88000057 21 230017 Serial Numbers: 200017; 200023; 200024; 200036; 200045; 200047; 230002; 230003; 230004; 200059; 230005; 230006; 230007; 230008; 230009; 230010; 230011; 230012; 230013; 230014; 230015; 230016; 230017;
Where was it sold?
U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 88521This product is part of a recall event; the main page for the event is uEXPLORER PET/CT System recalled by Shanghai United Imaging.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | uEXPLORER PET/CT System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Other | Nationwide |
More recalls from Shanghai United Imaging Healthcare
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ltd Positron Emission Tomography (PET) and Computed Tomography (CT) recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | 4 states |
| Device | CLASS II | Digital Medical X-ray Imaging System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | uEXPLORER PET/CT System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Other | Nationwide |
| Device | CLASS II | Digitial Medica X-ray Imagining System recalled | Shanghai United Imaging Healthcare | Other | Nationwide |
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| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |