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
This recall is currently active, issued April 25, 2024. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- March 22, 2024
- Posted
- April 25, 2024
- Recall Number
- Z-1690-2024
- Quantity
- 12,936 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
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
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 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.
Root Cause
Component design/selection
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