FDA Medical Device Recalls (openFDA)
PHILIPS MEDICAL SYSTEMS: Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
- Recall number
- Z-1054-2024
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Product
- Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
- Status
- Open, Classified
- Initiated
- 2023-12-13
- Posted
- 2024-02-08
- Terminated
- not on file
- Reason
- A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
- Root cause
- Under Investigation by firm
- Action
- An Urgent Medical Device Correction notice (2023-PD-CTAMI-017) dated December 13, 2023 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions.
- Quantity
- US: 1
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.
- Lot, serial or model codes
- UDI-DI: 00884838103627, serial number: 1005.
- 510(k) numbers
- ["K212875"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3017726341
- 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