CLASS II ONGOING Device recall · Reported 16 Dec 2020 · FDA Enforcement Report
Trinias, Digital Angiography System containing a MH recalled
Shimadzu Medical Systems is recalling Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support, distributed nationwide in the US. The recall was initiated on 18 Nov 2020 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-0555-2021
- FDA event ID
- 86846
- Recalling firm
- Shimadzu Medical Systems, Torrance, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Nov 2020
- FDA classified
- 10 Dec 2020
- Reported
- 16 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 18 Nov 2020 | Recall initiated by company | |
| 10 Dec 2020 | Classified by FDA | +22 days |
| 16 Dec 2020 | 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 firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
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
Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
Where it was distributed
US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
Nationwide CaliforniaConnecticutIllinoisIndianaKentuckyLouisianaMichiganMontanaNorth CarolinaNew YorkOhioSouth CarolinaTennessee
Questions about this recall
Why was it recalled?
The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.
Which lots are affected?
Affected Serial Numbers: 41EFCD7A6001 41EFC73A5001, 41EFCD79C001, 41EFD3B9C001, 41EFFF79C001, 41EFD3B9A001, 41EFCD79A001, 41EFFF79A001, 41F005B91001, 41F005B8C001, 41EFCD78B001, 41EFCD77C001, 41E58C776001, 41E58C777001, 41E58C775001, 41E58C773001, 41E58C76B001, 41E58C769001, 41E58C766001, 41E58C765001, 41E58C757001, 41B24774C001, 41B247746001,
Where was it sold?
US Nationwide distribution including in the states of KY, CA, MI, OH, CT, MI, NY, SC, NC,IN, IL, TN, LA, CT, MT.
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
2 other products · FDA event 86846This product is part of a recall event; the main page for the event is MH-200S, system with Ceiling Suspended C-arm Support recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MH-200S, system with Ceiling Suspended C-arm Support recalled | Shimadzu Medical Systems | Device Malfunction | Nationwide | |
| CLASS II | Bransist Safire, Digital Angiography System recalled | Shimadzu Medical Systems | Device Malfunction | Nationwide |
More recalls from Shimadzu Medical Systems
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Model: X-ray R/F System FLUOROspeed X1 recalled | Shimadzu Medical Systems | Other | 37 states |
| Device | CLASS II | Model: X-ray TV System Sonialvision G4 recalled | Shimadzu Medical Systems | Other | 37 states |
| Device | CLASS II | Model: X-ray TV Sysstem Sonialvision safire17 recalled | Shimadzu Medical Systems | Other | 37 states |
| Device | CLASS II | Digital Angiography System Shimadzu Trinias Generator recalled | Shimadzu Medical Systems | Other | 15 states |
| Device | CLASS II | Digital Angiography System Bransist safire Generator recalled | Shimadzu Medical Systems | Other | 15 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |