Philips North America Llc: Patient Information Center iX Software Recalled for Data Transfer Failure

What You Should Do

1. Identify if your facility is using Patient Information Center iX or Patient Information Center iX Expand running Software Version 4.x.
2. Check the specific serial numbers of your units against the affected list, which includes identifiers such as 7G6G-7PGV-W, 5971-2NL7-Z, 6D62-19MD-9, 463N-67ME-X, 6U1W-7TJA-9, and others listed in the product documentation.
3. Immediately verify that all Event Catalog information has been correctly saved and is present on any unit where data was recently transferred or copied.
4. Contact your healthcare provider or Philips North America Llc at their Cambridge, MA headquarters to receive instructions on software updates or corrective patches.
5. Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program.
6. For additional questions or further assistance, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products