FDA Medical Device Recalls (openFDA)
Toshiba American Medical Systems Inc: INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
- Recall number
- Z-0752-2016
- Recalling firm
- Toshiba American Medical Systems Inc
- Product
- INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
- Status
- Terminated
- Initiated
- 2015-08-14
- Posted
- 2016-02-09
- Terminated
- 2016-05-18
- Reason
- When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Toshiba's planned action to bring into compliance: 1.Affected customers will be notified using the Customer Notification Letter you provided, 2. revised system software will be installed on the systems to prevent this occurrence from happening, 3. the corrections will be made free of charge, and 4. the corrections will be completed by April 4, 2016. For further questions, please call 1- 800 521-1968.
- Quantity
- 4
- Distribution
- US Nationwide Distribution to OH and NY
- Lot, serial or model codes
- Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
- 510(k) numbers
- ["K120073","K133535","K143225","K152696"]
- PMA numbers
- not on file
- Product code
- OWB
- 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