Recall Z-1690-2024— Philips North America Llc

Name: FDA recall Z-1690-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-22

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2024-03-22. It names one FDA 510(k) clearance: K153702. Product: 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: 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.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2024-03-22
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K153702 — M3290B Philips IntelliVue Information Center iXPhilips Medical Systems·cleared 2016-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.