Recall Z-1607-2016— Toshiba American Medical Systems Inc

Name: FDA recall Z-1607-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-24

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2016-04-24, terminated 2017-02-22. It names one FDA 510(k) clearance: K140651. 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.. Reason: Potential degradation of detector performance..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2016-04-24
Terminated: 2017-02-22
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

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.

Reason for recall

Potential degradation of detector performance.

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