Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
- Company
- Philips Medical Systems
- Recall Initiated
- December 13, 2023
- Posted
- February 8, 2024
- Recall Number
- Z-1054-2024
- Quantity
- US: 1
- Firm Location
- Cambridge, MA
Reason for Recall
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
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 / Code Info
UDI-DI: 00884838103627, serial number: 1005.
Root Cause
Under Investigation by firm
Action Taken
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.