CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report
Toshiba America Medical Systems Angio WorkStation recalled
Toshiba American Medical Systems is recalling Toshiba America Medical Systems Angio WorkStation: Xidf-AWS801v6.00, v6.01, and V6.10, distributed in 11 states. The recall was initiated on 24 Feb 2016 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-2188-2016
- FDA event ID
- 74473
- Recalling firm
- Toshiba American Medical Systems, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Feb 2016
- FDA classified
- 18 Jul 2016
- Reported
- 27 Jul 2016
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 24 Feb 2016 | Recall initiated by company | |
| 18 Jul 2016 | Classified by FDA | +145 days |
| 27 Jul 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.
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 America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
Where it was distributed
US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.
ArizonaCaliforniaDelawareFloridaGeorgiaIllinoisMassachusettsMissouriNorth CarolinaNew YorkTexas
Questions about this recall
Why was it recalled?
During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.
Which lots are affected?
Model Number - XIDF-AWS801
Where was it sold?
US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.
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 |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |