Class 2 Device Recall Philips IntelliSpace

• Date Initiated by Firm: April 04, 2024
• Date Posted: February 28, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1252-2025
• Recall Event ID: 96129
• 510(K)Number: K153022
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Philips IntelliSpace Cardiovascular software, Model 830089.
• Code Information: Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.
• FEI Number: 3000976525
• Recalling Firm/ Manufacturer: Philips Medical Systems Nederland B.V.; High Tech Campus 36; Eindhoven Netherlands
• For Additional Information Contact: Informatics Customer Support; 800-669-1328
• Manufacturer Reason for Recall: Study data is not able to be archived, copied, or exported with the cardiovascular software version.
• FDA Determined Cause: Software design
• Action: The recalling firm initially issued an "Important Product Notice" dated 3/12/2024 which their consignees received on 4/4/2024 informing them that Philips had identified an issue with the IntelliSpace Cardiovascular software version 7.0 where study data is not able to be archived, copied, or exported. The notice was to explain the issue and under what circumstances it can occur, the affected products and how to identify them, the actions the customer can take to minimize the effect of the issue, and the actions planned by Philips to correct the issue. The actions were: (1) The customer may continue to use the system in accordance with its intended use; (2) If study data cannot be archived, exported, or copied from ISCV via DICOM or to a CD, update the "Reason for Study" field using less than 64 characters; (3) Circulate the notice to all users of the system so they are aware of the issue; and (4) Retain the letter with the system until Philips has implemented the software correction. Philips will contact the customer to schedule a time for a Field Service Engineer to visit their site and install a software solution to resolve the issue. No response form was enclosed. A follow-up Urgent Medical Device Correction letter dated 1/8/2025 was issued on 1/10/2025 to the U.S. consignees who have not yet received the software correction. The letter supersedes the initial 3/12/2024 letter. The 1/8/2025 letter contains updated information with respect to the potential hazard/harm associated with the issue based on the revised Health Hazard Evaluation (HHE Rev C, 02-Jan-2025). The letter also had a response form attached for completion and return no later than 30 days after receipt of the letter.
• Quantity in Commerce: 139
• Distribution: US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.
• 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 = LLZ