Apr

2010

Aplio80, Xario Software, Cl Il Aplio 50

Company:Toshiba American Medical Systems Inc.
Date of Enforcement Report 3/31//2010
Class:ll

PRODUCT
1) Aplio 50; SSA-700A; software version 5.5r002. Recall # Z-1171-2010;
2) Aplio 80; SSA-770A; software version 5.5r002. Z-1172-2010;
3) Xario; SSA-660A; software version 1.0 and later. Recall # Z-1173-2010

REASON
Toshiba America Medical System Inc initiated a field corrective action on Aplio 50; SSA-700A; software version 5.5r002 and later, Aplio 80; SSA-700A; software version 5.5r002 and later, and Xario; SSA-660A; software version 1.0 and later, because the product does not meet the Safety Standard requirements.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin CA, by letter on November 12, 2007.
Manufacturer: Toshiba Electron Tubes & Devices Co., Ltd., Otawa-Shi, Tochigi, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
200 units

DISTRIBUTION
Nationwide

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Aplio80, Xario Software, Cl Il Aplio 50

Amy Sellers

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