PHILIPS MEDICAL SYSTEMS: Spectral CT Imaging Systems Recalled for Software Labeling Error

What You Should Do

1. Identify if your facility is using Spectral CT on Rails (Model 728334, Software Version 5.1.0.X) or Spectral CT 7500 (Models 728333 or 728340, Software Version 5.0).
2. Check the device serial numbers against the affected list. For Spectral CT on Rails, check for serial number 1005. For Spectral CT 7500, check for serial numbers such as 10197, 10182, 10175, 10192, and others listed in the recall documentation.
3. Verify the Unique Device Identifier (UDI-DI) on your equipment: 00884838103627 for Spectral CT on Rails or 00884838101111 for Spectral CT 7500.
4. If you are a healthcare provider using these systems, exercise extreme caution when reviewing captured images and verify patient identity through secondary means until the software is updated.
5. Contact Philips Medical Systems at their Cambridge, Massachusetts headquarters or through your local service representative to schedule a software correction or for further technical instructions.
6. Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.
7. For additional questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products