CLASS II ONGOING Device recall · Reported 19 Oct 2022 · FDA Enforcement Report
Positron Emission Tomography and Computed Tomography System recalled
Shanghai United Imaging Healthcare is recalling Positron Emission Tomography and Computed Tomography System, distributed in California, Michigan, Texas, Wisconsin. The recall was initiated on 30 May 2022 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-0087-2023
- FDA event ID
- 90888
- Recalling firm
- Shanghai United Imaging Healthcare, Shanghai, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 May 2022
- FDA classified
- 13 Oct 2022
- Reported
- 19 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 30 May 2022 | Recall initiated by company | |
| 13 Oct 2022 | Classified by FDA | +136 days |
| 19 Oct 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Where it was distributed
Distribution to US states of TX, WI, CA, and MI
Questions about this recall
Why was it recalled?
The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.
Which lots are affected?
UDI-DI/Serial Numbers: 06971576832026/230002, 230003, 230004, 230005, 230006, 230007, 230008, 230009, 230010, 230011, 230012, 230013, 230014, 230015, 230016, 230017, 230019, 230020, 230021, 230022, 230023, 230024, 230025, 230026, 230027, 230028, 230029, 230030, 230031, 230032, 230033, 232001
Where was it sold?
Distribution to US states of TX, WI, CA, and MI
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.
More recalls from Shanghai United Imaging Healthcare
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System 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 | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System 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 | Nationwide |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |