Z-1607-2016Class II

Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is...

Name: Z-1607-2016 Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is...
Creator: Toshiba American Medical Systems Inc
Published: 2016-04-24
License: https://open.fda.gov/license/

Canon Medical Systems USA, Inc. / initiated 2016-04-24 / Terminated / root cause: design

FDA source

Toshiba American Medical Systems Inc began a recall of Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion... on 2016-04-24. FDA classified it as Class II and gives the reason as "Potential degradation of detector performance". 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-1607-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-24
Posted: 2016-05-04
Terminated: 2017-02-22
Recalling firm: Canon Medical Systems USA, Inc.
Product: Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Potential degradation of detector performance.
Root cause tag: design
FDA root cause: Device Design
Action: Toshiba sent an Urgent Medical Device Correction letter dated April 24, 2016 to all affected customers. The letter informed customers that Toshiba America Medical Systems is bringing attention to a potential problem with the Celestion PET/CT System. The letter informed the customers of a potential degradation of detector performance and informed the customers of the problems and the corrective actions to be taken. Customers were instructed to complete and return the attached form and fax it to (877) 349-3054 or be sent via email to [email protected]. Customers with questions were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
Quantity in commerce: 3 units
Distribution: US Distribution to WI and NV.
Product codes and lots: Serial No. 3BA1572002, 3BA1562001, 2881492002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1607-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1607-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-04

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)