—#206965

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

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K153702
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

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

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

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.

Timeline

Recall initiated: 2024-03-22
Posted by FDA: 2024-04-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206965. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.