Recall Z-0005-2016— Toshiba American Medical Systems Inc

Name: FDA recall Z-0005-2016
Creator: U.S. Food and Drug Administration
Published: 2015-05-08

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2015-05-08, terminated 2015-12-03. It names one FDA 510(k) clearance: K140651. Product: Celesteion PCA-9000A/2 PET/CT System. Reason: 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..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2015-05-08
Terminated: 2015-12-03
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K140651 — CELESTEION, PCA-9000A/2Toshibamedical Systems Corporation·cleared 2014-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.