CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report
Toshiba Infinix X-Ray Interventional System Infx-8000V/UU recalled
Toshiba American Medical Systems is recalling Toshiba Infinix X-Ray Interventional System Infx-8000V/UU, distributed nationwide in the US. The recall was initiated on 12 May 2014 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-1714-2014
- FDA event ID
- 68363
- Recalling firm
- Toshiba American Medical Systems, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 May 2014
- FDA classified
- 4 Jun 2014
- Reported
- 11 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 12 May 2014 | Recall initiated by company | |
| 4 Jun 2014 | Classified by FDA | +23 days |
| 11 Jun 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.
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
Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.
Where it was distributed
Nationwide Distribution including CA and IN
Questions about this recall
Is Toshiba Infinix X-Ray Interventional System Infx-8000V/UU recalled?
Yes. Toshiba American Medical Systems recalled Toshiba Infinix X-Ray Interventional System Infx-8000V/UU on 12 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1714-2014.
Why was it recalled?
Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt, the movement of longitudinal tilt does not stop.
Which lots are affected?
Serial Numbers: ULD1412014, UUC13Z2011, A4A113Z2001.
Where was it sold?
Nationwide Distribution including CA and IN
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 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 |
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