Z-0005-2016Class II

Celesteion PCA-9000A/2 PET/CT System

Name: Z-0005-2016 Celesteion PCA-9000A/2 PET/CT System
Creator: Toshiba American Medical Systems Inc
Published: 2015-05-08
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2015-05-08 / Terminated / root cause: design

FDA source

Toshiba American Medical Systems Inc began a recall of Celesteion PCA-9000A/2 PET/CT System on 2015-05-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0005-2016
Classification: Class II
Status: Terminated
Initiated: 2015-05-08
Posted: 2015-10-07
Terminated: 2015-12-03
Recalling firm: Canon Medical Systems USA, Inc.
Product: Celesteion PCA-9000A/2 PET/CT System
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1
Distribution: US Distribution to the state of Nevada.
Product codes and lots: Model: TSX-301 CI6A with system software V7.0 SPOO04J

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0005-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0005-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-07

Product code KPS

K140651Class IICelesteion, Pca-9000A/2Toshibamedical Systems Corporation / cleared 2014-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)