CLASS II ONGOING Device recall · Reported 20 Mar 2024 · FDA Enforcement Report
Shimadzu, Trinias, Digital Angiography System recalled
Shimadzu Corporation Medical Systems Division is recalling Shimadzu, Trinias, Digital Angiography System, distributed nationwide in the US. The recall was initiated on 29 Jan 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-1292-2024
- FDA event ID
- 93933
- Recalling firm
- Shimadzu Corporation Medical Systems Division, Kyoto, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jan 2024
- FDA classified
- 14 Mar 2024
- Reported
- 20 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 29 Jan 2024 | Recall initiated by company | |
| 14 Mar 2024 | Classified by FDA | +45 days |
| 20 Mar 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
Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
Product as listed by the FDA
Shimadzu, Trinias, Digital Angiography System
Where it was distributed
US Nationwide distribution in the states of OH.
Questions about this recall
Why was it recalled?
Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
Which lots are affected?
Serial Number: 41EFFF7D3001/UDI: (01)04540217058020
Where was it sold?
US Nationwide distribution in the states of OH.
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 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 | Sonialvision G4 is a multi-purpose X-ray R/F system 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 | Over-Head Ceiling Tube Support, CH-200, CH-200M, Used recalled | Shimadzu Corporation Medical Systems Division | Other | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |