Philips North America Llc: Patient Information Center (PIC) iX Power Supply Recalled for Failure Risk

Agency Publication Date: April 25, 2024

Summary

Approximately 12,936 Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS) units are being recalled because they may fail and cause the patient monitoring system to shut down without warning. This failure occurs due to a lack of power from the UPS, which supports the central monitoring system used by healthcare providers. If the system shuts down, there could be a critical delay in detecting changes in a patient's condition, potentially leading to patient harm. The affected models include the APC (Schneider Electric) SCL500RM1U and SCL500RMI1U units manufactured between 2021 and 2022.

Risk

The power supply unit can fail suddenly, causing the connected patient information system to lose power and turn off. This prevents medical staff from receiving vital signs or alerts, which may delay life-saving medical responses if a patient's health deteriorates while the system is offline.

What You Should Do

Check the serial number on the back of your APC UPS unit to see if it is included in this recall. Look for the format 5SYYWW123456, where the 3rd and 4th digits are the year and the 5th and 6th digits are the week of manufacture.
Verify if your 120V Model SCL500RM1U has a serial number date code (YYWW) prior to 2237 (Week 37 of 2022).
Verify if your 230V Model SCL500RMI1U has a serial number date code (YYWW) prior to 2241 (Week 41 of 2022).
If your unit is affected, contact Philips North America or your healthcare facility's biomedical engineering department immediately to discuss power redundancy or replacement options.
Contact Philips North America or your healthcare provider for further instructions and potential remedy information regarding these power supply devices.
For additional questions or to report a device failure, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: APC (Schneider Electric) 120V Uninterruptable Power Supply (UPS) for Philips PIC iX

Model / REF:

SCL500RM1U

Lot Numbers:

Serial number date codes prior to 2237

Date Ranges: Manufactured prior to week 37 of 2022

Product: APC (Schneider Electric) 230V Uninterruptable Power Supply (UPS) for Philips PIC iX

Model / REF:

SCL500RMI1U

Lot Numbers:

Serial number date codes prior to 2241

Date Ranges: Manufactured prior to week 41 of 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94340

Status: Active

Manufacturer: Philips North America Llc

Sold By: Philips North America Llc; Schneider Electric IT Corporation

Manufactured In: United States

Units Affected: 12,936 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check the serial number on the back of your APC UPS unit to see if it is included in this recall. Look for the format 5SYYWW123456, where the 3rd and 4th digits are the year and the 5th and 6th digits are the week of manufacture.

Verify if your 120V Model SCL500RM1U has a serial number date code (YYWW) prior to 2237 (Week 37 of 2022).

Verify if your 230V Model SCL500RMI1U has a serial number date code (YYWW) prior to 2241 (Week 41 of 2022).

If your unit is affected, contact Philips North America or your healthcare facility's biomedical engineering department immediately to discuss power redundancy or replacement options.

Contact Philips North America or your healthcare provider for further instructions and potential remedy information regarding these power supply devices.

For additional questions or to report a device failure, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: APC (Schneider Electric) 120V Uninterruptable Power Supply (UPS) for Philips PIC iX

Model / REF:

SCL500RM1U

Lot Numbers:

Serial number date codes prior to 2237

Date Ranges: Manufactured prior to week 37 of 2022

Product: APC (Schneider Electric) 230V Uninterruptable Power Supply (UPS) for Philips PIC iX

Model / REF:

SCL500RMI1U

Lot Numbers:

Serial number date codes prior to 2241

Date Ranges: Manufactured prior to week 41 of 2022