CLASS II Device recall · Reported 7 Jun 2017 · FDA Enforcement Report
Angio WorkStation (Xidf-AWS801) used in conjunction recalled
Toshiba American Medical Systems is recalling Angio WorkStation (Xidf-AWS801) used in conjunction with your Infinix System, distributed in 28 states. The recall was initiated on 1 Feb 2017 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-2109-2017
- FDA event ID
- 77195
- Recalling firm
- Toshiba American Medical Systems, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Feb 2017
- FDA classified
- 30 May 2017
- Reported
- 7 Jun 2017
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Feb 2017 | Recall initiated by company | |
| 30 May 2017 | Classified by FDA | +118 days |
| 7 Jun 2017 | 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
It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
Product as listed by the FDA
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
Where it was distributed
US Distribution to the states of :LA, IL, NY, FL, MA, TN, MO, GA, CA, DE, MO, AL, ID, MN, TX, CT, PA, MS, OH, NC, NV, W VA, WA, AR, NJ, MD, OK, IN and NH.
AlabamaArkansasCaliforniaConnecticutDelawareFloridaGeorgiaIdahoIllinoisIndianaLouisianaMassachusettsMarylandMinnesotaMissouriMississippiNorth CarolinaNew HampshireNew JerseyNevada
Questions about this recall
Why was it recalled?
It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.
Which lots are affected?
S/N : 8181622393
Where was it sold?
US Distribution to the states of :LA, IL, NY, FL, MA, TN, MO, GA, CA, DE, MO, AL, ID, MN, TX, CT, PA, MS, OH, NC, NV, W VA, WA, AR, NJ, MD, OK, IN and NH.
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.
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