Toshiba American Medical Systems Inc: Medical Device Recall in 2016 - (Recall #: Z-1607-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 24, 2016

Date Posted: May 11, 2016

Recall Number: Z-1607-2016

Event ID: 74005

Reason for Recall:

Potential degradation of detector performance.

Status: Terminated

Product Quantity: 3 units

Code Information:

Serial No. 3BA1572002, 3BA1562001, 2881492002

Distribution Pattern:

US Distribution to WI and NV.

Voluntary or Mandated:

Voluntary: Firm initiated