FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: INFX-8000H Fluoroscopic X-Ray Systems
- Recall number
- Z-0845-2018
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- INFX-8000H Fluoroscopic X-Ray Systems
- Status
- Terminated
- Initiated
- 2017-12-29
- Posted
- not on file
- Terminated
- 2023-11-29
- Reason
- During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
- Root cause
- Process control
- Action
- A recall notification letter was sent to affected consignees on 12/29/2017. The following information was included in the notification letter: Should this problem occur prior to the above corrective action and in the middle of a clinical case, you will be able continue the case tentatively. The x-ray emissions will be still available and the inhibited ceiling support device can be overridden by pressing the override switch on the left side of the operation console. If any abnormalities are found during use, please stop using your system and contact your Toshiba service representative. Please share this information with all users and reviewing radiologist as well as clinical engineering and the biomedical group at your facility.
- Quantity
- 2 units
- Distribution
- United States
- Lot, serial or model codes
- Serial Numbers: A5B1672001, AFA1692002
- 510(k) numbers
- ["K082830"]
- PMA numbers
- not on file
- Product code
- JAA
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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