CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
Brand Name: Probeat Product Name recalled by Hitachi America, Ltd.
Hitachi America, Ltd., Particle Therapy Division is recalling Brand Name: Probeat Product Name: Probeat-v Model/Catalog Number: N/A, distributed nationwide in the US. The recall was initiated on 27 May 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-3127-2024
- FDA event ID
- 94928
- Recalling firm
- Hitachi America, Ltd., Particle Therapy Division, Santa Clara, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 May 2024
- FDA classified
- 12 Sep 2024
- Reported
- 18 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 27 May 2024 | Recall initiated by company | |
| 12 Sep 2024 | Classified by FDA | +108 days |
| 18 Sep 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
During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
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
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
Where it was distributed
U.S. Nationwide distribution in the states of TN, TX, and WA.
Questions about this recall
Is Brand Name: Probeat Product Name: Probeat-v Model/Catalog Number: N/A recalled?
Yes. Hitachi America, Ltd., Particle Therapy Division recalled Brand Name: Probeat Product Name: Probeat-v Model/Catalog Number: N/A on 27 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-3127-2024.
Why was it recalled?
During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
Which lots are affected?
Lot Code: This products has no UDI. Serial No.: 2015B01
Where was it sold?
U.S. Nationwide distribution in the states of TN, TX, and WA.
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 21 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 Hitachi America, Ltd., Particle Therapy Division
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Brand Name: Probeat Product Name: Probeat-cr Model/Catalog Number recalled | Hitachi America, Ltd., Particle Therapy Division | Device Malfunction | Nationwide |
| Device | CLASS II | Brand Name: Probeat Product Name: Probeat-fr Model/Catalog Number recalled | Hitachi America, Ltd., Particle Therapy Division | Device Malfunction | Nationwide |
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