CLASS II ONGOING Device recall · Reported 13 Nov 2024 · FDA Enforcement Report
Sonialvision G4 is a multi-purpose X-ray R/F system recalled
Shimadzu Corporation Medical Systems Division is recalling Sonialvision G4 is a multi-purpose X-ray R/F system, distributed nationwide in the US. The recall was initiated on 6 Sep 2024 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-0316-2025
- FDA event ID
- 95450
- Recalling firm
- Shimadzu Corporation Medical Systems Division, Kyoto, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Sep 2024
- FDA classified
- 7 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 6 Sep 2024 | Recall initiated by company | |
| 7 Nov 2024 | Classified by FDA | +62 days |
| 13 Nov 2024 | 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
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
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
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
Where it was distributed
US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.
Nationwide ArkansasCaliforniaColoradoConnecticutFloridaHawaiiIowaIllinoisLouisianaMassachusettsMarylandMinnesotaMontanaNorth CarolinaNebraskaNew YorkOhioTennesseeTexasWashington
Questions about this recall
Why was it recalled?
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
Which lots are affected?
UDI-DI: 04540217064809, 04540217064816. Serial Numbers: 41C3518D7001, 41C3518E4001, 41C3536D9001
Where was it sold?
US Nationwide distribution in the states of CA, CT, MA, WV, OH, NY, IA, NE, MN, IL, FL, NC, HI, LA, MD, MT, WA, AR, TX, TN, CO.
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 95450| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The FLUOROspeed is intended to be used as a universal recalled | Shimadzu Corporation Medical Systems Division | Device Malfunction | Nationwide |
More recalls from Shimadzu Corporation Medical Systems Division
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ceiling Type X-Ray Tube Support recalled by Shimadzu Corporation Medical | Shimadzu Corporation Medical Systems Division | Device Malfunction | Nationwide |
| Device | CLASS II | The FLUOROspeed is intended to be used as a universal recalled | Shimadzu Corporation Medical Systems Division | Device Malfunction | Nationwide |
| Device | CLASS II | Trinias unity, Digital Angiography System with Catheterization Table recalled | Shimadzu Corporation Medical Systems Division | Other | Nationwide |
| Device | CLASS II | Shimadzu, Trinias, Digital Angiography System recalled | Shimadzu Corporation Medical Systems Division | Other | Nationwide |
| Device | CLASS II | Over-Head Ceiling Tube Support, CH-200, CH-200M, Used recalled | Shimadzu Corporation Medical Systems Division | Other | Nationwide |
Other Imaging Equipment recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |