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-0218-2026
- 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. Computed Tomography X-ray System, Model:uCT 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)06971576831036/ Serial Numbers: 353020 353021 353023 353045 353049 354001 354002 354003 354004 354005 354006 354007 354008 354009 354010 354011 354012 354013 354014 354015 354016 354017
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 |