FDA Device Recall Z-0005-2016: Toshiba American Medical Systems Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0005-2016.

Recall Res Number

Z-0005-2016

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

2015-10-07

Date Terminated

2015-12-03

Product Code

KPS

Event Number

71763

Product Quantity

Product Description Celesteion PCA-9000A/2 PET/CT System

Reason for Recall It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.

Action Details Planned Action by Toshiba Medical America Systems to address the defect: a. A notification will be sent to the customer with affected system in compliance with 21 CFR1 003.21 upon approval by the Secretary. b. To correct this issue revised software will be installed on the system to prevent this occurrence from happening. The consignee will be contacted by their Toshiba service representative for an appointment when the revised software becomes available. c. The customer will be advised to do the following until the corrective measures have been taken, i.e., revised software installed on their systems. If you have any questions please contact your local Toshiba Representative at (800) 521-1968.

Distribution Pattern US Distribution to the state of Nevada.

Code Information / Serial Numbers Model: TSX-301 CI6A with system software V7.0 SPOO04J

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Medical Device Recall: Z-0005-2016

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer