Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneide...

FDA Device Recall #Z-1690-2024 — Class II — March 22, 2024

Recall Summary

Recall Number Z-1690-2024
Classification Class II — Moderate risk
Date Initiated March 22, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips North America Llc
Location Cambridge, MA
Product Type Devices
Quantity 12,936 units

Product Description

Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model: SCL500RMI1U

Reason for Recall

Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to the delay in the detection of a change in a patient condition

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bolivia, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Ecuador, Estonia, Fiji, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Oman, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, United Kingdom, Utd. Ara Emir.

Lot / Code Information

1. SCL500RM1U (only serial number date codes prior to 2237*) 2. SCL500RMI1U (only serial number date codes prior to 2241*) Example unit serial number is 5S"2104"08943, meaning it was manufactured during week 04 of the year 2021. The serial number format is 5SYYWW123456.

Other Recalls from Philips North America Llc

Recall # Classification Product Date
Z-1316-2026 Class II IQon Spectral CT; Product Code (REF): 728332; Jan 7, 2026
Z-1318-2026 Class II Spectral CT 7500 on Rails; Product Code (REF):... Jan 7, 2026
Z-1317-2026 Class II Spectral CT; Product Code (REF): 728333; Jan 7, 2026
Z-1315-2026 Class II Brilliance iCT; Product Code (REF): 728306; Jan 7, 2026
Z-1033-2026 Class II Philips Smart-hopping 2.0 AP 1.4 GHz. Patient M... Dec 12, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.