FDA Device Recall Z-0013-2016: Toshiba American Medical Systems Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0013-2016.

Recall Res Number

Z-0013-2016

Recalling Firm / Manufacturer

Toshiba American Medical Systems Inc

FEI Number

2020563

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2015-05-08

Date Posted

2015-10-09

Date Terminated

2016-10-26

Product Code

JAK

Event Number

71923

Product Quantity

459

Product Description Toshiba Aquilion CT System TSX-101A

Reason for Recall If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

Action Details Toshiba America Medical Planned Action to bring defect into Compliance: a. A notification will be sent to all consignees with affected systems in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on each system to prevent this occurrence from happening. Each consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. Each consignee will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on their systems. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Toshiba America Medical Systems, Inc. will implement this CAP by February 1, 2016. If you have any questions please contact your local Toshiba Representative at (800) 521-1968.

Distribution Pattern US Distribution including Puerto Rico

Code Information / Serial Numbers system software V6.0 or later

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Medical Device Recall: Z-0013-2016

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer