Class 2 Device Recall Philips

• Date Initiated by Firm: March 22, 2024
• Date Posted: April 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1690-2024
• Recall Event ID: 94340
• 510(K)Number: K153702
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• 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
• Code Information: 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.
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer 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
• FDA Determined Cause: Component design/selection
• Action: 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
• Quantity in Commerce: 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, 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS