CLASS II Device recall · Reported 17 Feb 2016 · FDA Enforcement Report
Infx-8000V Bi-Plane X-Ray Interventional System X-ray systems recalled
Toshiba American Medical Systems is recalling Infx-8000V Bi-Plane X-Ray Interventional System X-ray systems, distributed nationwide in the US. The recall was initiated on 14 Aug 2015 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-0752-2016
- FDA event ID
- 73078
- Recalling firm
- Toshiba American Medical Systems, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Aug 2015
- FDA classified
- 9 Feb 2016
- Reported
- 17 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 14 Aug 2015 | Recall initiated by company | |
| 9 Feb 2016 | Classified by FDA | +179 days |
| 17 Feb 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
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
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Where it was distributed
US Nationwide Distribution to OH and NY
Questions about this recall
Why was it recalled?
When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
Which lots are affected?
Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
Where was it sold?
US Nationwide Distribution to OH and NY
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 Toshiba American Medical Systems
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Diagnostic Ultrasound System, Aplio I-series recalled | Toshiba American Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Infx-8000V Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
| Device | CLASS II | Infx-8000H Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
| Device | CLASS II | Infx-8000F Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
| Device | CLASS II | Infx-8000C Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
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