CLASS II Device recall · Reported 12 Oct 2016 · FDA Enforcement Report
Toshiba America Medical Systems recalled by Toshiba American Medical
Toshiba American Medical Systems is recalling Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2 Scanner, distributed in 35 states. The recall was initiated on 25 Apr 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-0048-2017
- FDA event ID
- 74871
- Recalling firm
- Toshiba American Medical Systems, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2016
- FDA classified
- 6 Oct 2016
- Reported
- 12 Oct 2016
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 25 Apr 2016 | Recall initiated by company | |
| 6 Oct 2016 | Classified by FDA | +164 days |
| 12 Oct 2016 | 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
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
Product as listed by the FDA
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Where it was distributed
US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.
AlabamaArkansasCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIndianaKansasKentuckyLouisianaMassachusettsMichiganMinnesotaMississippiMontanaNorth Carolina
Questions about this recall
Why was it recalled?
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
Which lots are affected?
XL 700
Where was it sold?
US Distribution to the states of: PA, IA, MA, SD, MI, LA, KY, NC, NY, AR, IN, WI, OH, TY, FL, WV, WA, CT, MS, AL, ND, CO, HI, NO, MN, ID, OH, GA, MT, LA, NM, VT, TN, CA, NH, NJ, NE, SC and KS.
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.
Other products in this recall event
3 other products · FDA event 74871This product is part of a recall event; the main page for the event is Toshiba America Medical Systems recalled by Toshiba American Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Toshiba America Medical Systems recalled by Toshiba American Medical | Toshiba American Medical Systems | Other | 35 states | |
| CLASS II | Toshiba America Medical Systems recalled by Toshiba American Medical | Toshiba American Medical Systems | Other | 35 states | |
| CLASS II | Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/ Scanner recalled | Toshiba American Medical Systems | Other | 35 states |
More recalls from Toshiba American Medical Systems
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|---|---|---|---|---|---|
| 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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| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |