FDA Medical Device Recalls (openFDA)
Philips North America: Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
- Recall number
- Z-0306-2024
- Recalling firm
- Philips North America
- Product
- Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
- Status
- Open, Classified
- Initiated
- 2023-10-09
- Posted
- 2023-11-15
- Terminated
- not on file
- Reason
- When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.
- Root cause
- Under Investigation by firm
- Action
- An URGENT Medical Device Correction notification letter dated 10/9/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users. Below are short-term precautions to take until the permanent solution is installed. Leave the audible preparation indication alert turned on, set as default in the factory settings, and wait for the audible alert before pressing the foot pedal. If you have disabled the audible alert, you can turn it back on by following instructions provided in Section 4: Preparing for an Examination of the IFU. Wait for the blue arrow to appear on the screen on the console and in the procedure room, prior to depressing the fluoroscopy pedal. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. Actions planned by Philips to correct the problem Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and install the software update (FCO 72800805) to resolve the issue. Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of MN.
- Lot, serial or model codes
- UDI-DI: 00884838103627; Lot Code: 1005
- 510(k) numbers
- ["K212875"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3006648320
- Firm city
- Cambridge
- Firm state
- MA
- 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