—#205448

Product

Spectral CT on Rails: Software Version 5.1.0.X, model 728334.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K212875
Affected lot / code info: UDI-DI: 00884838103627, serial number: 1005.

Why it was recalled

A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-12-13
Posted by FDA: 2024-02-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205448. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.