PHILIPS MEDICAL SYSTEMS Spectral CT on Rails: Software Version 5.1.0.X, model 728334. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Brand
PHILIPS MEDICAL SYSTEMS
Lot Codes / Batch Numbers
UDI-DI: 00884838103627, serial number: 1005.
Products Sold
UDI-DI: 00884838103627, serial number: 1005.
PHILIPS MEDICAL SYSTEMS is recalling Spectral CT on Rails: Software Version 5.1.0.X, model 728334. due to A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026