CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report
Shanghai United Imaging Healthcare Co., Ltd recalled by UIH Technologies
UIH Technologies is recalling Shanghai United Imaging Healthcare Co., Ltd. The recall was initiated on 12 Sep 2025 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-0223-2026
- FDA event ID
- 97668
- Recalling firm
- UIH Technologies, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Sep 2025
- FDA classified
- 21 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 12 Sep 2025 | Recall initiated by company | |
| 21 Oct 2025 | Classified by FDA | +39 days |
| 29 Oct 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Product as listed by the FDA
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
Where it was distributed
US: OUS:
Questions about this recall
Why was it recalled?
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Which lots are affected?
UDI: (01)06971576832026/ Serial Numbers: 200017 200023 200024 200036 200045 200047 230002 230003 230004 230005 230006 230007 230008 230009 230011 230010 230012 230014 230013 200059 230015 230016 230017 230019 230020 230021 230022 230023 230024 230025 232001 200071 230026 230027 200072 230028 200074 230030 230029 200075 200076 230031 230032 230033 230034 230035 200079 200078 230037 230036 230038 230039 230040 230041 230042 230043 230044 230045 230047 230048 232002 202002 232003 232004 232005 230057 232006 232007 202004 232008 232009 202005 232010 202006 232011 202007 232012 232013 232014 230067 230068 230069 232015 232016 230070 230071 230073 202008 230072 230074 232017 202009 232018 232019 202010
Where was it sold?
US: OUS:
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
8 other products · FDA event 97668This product is part of a recall event; the main page for the event is Shanghai United Imaging Healthcare Co., Ltd recalled by UIH Technologies.
More recalls from UIH Technologies
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Shanghai United Imaging Healthcare Co., Ltd recalled by UIH Technologies | UIH Technologies | Other | TX |
| Device | CLASS II | Shanghai United Imaging Healthcare Co., Ltd recalled by UIH Technologies | UIH Technologies | Other | TX |
| Device | CLASS II | Shanghai United Imaging Healthcare Co., Ltd recalled by UIH Technologies | UIH Technologies | Other | TX |
| Device | CLASS II | Shanghai United Imaging Healthcare Co., Ltd recalled by UIH Technologies | UIH Technologies | Other | TX |
| Device | CLASS II | Shanghai United Imaging Healthcare Co., Ltd recalled by UIH Technologies | UIH Technologies | Other | TX |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |