FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: Celesteion PCA-9000A/2 PET/CT System
- Recall number
- Z-0005-2016
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- Celesteion PCA-9000A/2 PET/CT System
- Status
- Terminated
- Initiated
- 2015-05-08
- Posted
- 2015-10-07
- Terminated
- 2015-12-03
- Reason
- 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
- 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
- 1
- Distribution
- US Distribution to the state of Nevada.
- Lot, serial or model codes
- Model: TSX-301 CI6A with system software V7.0 SPOO04J
- 510(k) numbers
- ["K140651"]
- PMA numbers
- not on file
- Product code
- KPS
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28