Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporatio

FDA device recall Z-1690-2024 · posted 2024-04-25 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

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

Action taken

Philips issued Urgent Medical Device Correction Letter on 3/22/24. Letter states reason for recall, health risk and action to take: If your UPS fails : 1) Promptly take the UPS offline and plug any devices that had been attached to it into a different appropriate power source. Note: It is recommended that UPS devices intended for operation in network and server rooms be kept in a temperature and humidity controlled environment, ensuring adequate airflow around the UPS to prevent UPS device failure. This notice should be passed on to all those who need to be aware within your organization or to any organization where affected devices have been transferred. 5. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will replace the malfunctioning UPS. If you need any further information, please contact your local Philips representative, or call 1-800- 722- 9377. Philips Reference# 2024-CC-HPM-010

Root cause

Component design/selection

Status

Open, Classified

Product code

MHX

Quantity affected

12,936 units

Distribution

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,

Date initiated

2024-03-22

Date posted

2024-04-25

Location

Cambridge, MA

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