FDA Enforcement
Class II
Ongoing
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Recall: Z-1054-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-1054-2024
- Event ID
- 93798
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- PHILIPS MEDICAL SYSTEMS
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- December 13, 2023
- Classification Date
- February 8, 2024
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289, United States
Description
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Reason
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
Code Info
UDI-DI: 00884838103627, serial number: 1005.
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.
Quantity
US: 1