Toshiba American Medical Systems Inc: Medical Device Recall in 2015 - (Recall #: Z-0005-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Celesteion PCA-9000A/2 PET/CT System

Product Classification:

Class II

Date Initiated: May 8, 2015

Date Posted: October 14, 2015

Recall Number: Z-0005-2016

Event ID: 71763

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.

Status: Terminated

Product Quantity: 1

Code Information:

Model: TSX-301 CI6A with system software V7.0 SPOO04J

Distribution Pattern:

US Distribution to the state of Nevada.

Voluntary or Mandated:

Voluntary: Firm initiated