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U.S. Department of Health and Human Services

Class 2 Device Recall IntelliSpace Cardiovascular

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 Class 2 Device Recall IntelliSpace Cardiovascularsee related information
Date Initiated by FirmAugust 08, 2025
Date PostedSeptember 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2543-2025
Recall Event ID 97379
510(K)NumberK153022 
Product Classification System, image processing, radiological - Product Code LLZ
ProductIntelliSpace Cardiovascular, Software 8.0.0.4.
Code Information Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
FEI Number 3000976525
Recalling Firm/
Manufacturer		 Philips Medical Systems Nederland B.V.
High Tech Campus 36
Eindhoven Netherlands
For Additional Information ContactPhilips Informatics Customer Support
800-6691328
Manufacturer Reason
for Recall		Software issue that results in the display of outdated information.
FDA Determined
Cause 2		Software design
ActionAn URGENT Medical Device Correction notice dated 8/7/25 was mailed to consignees. The notification includes instructions for continued safe use of devices, which includes: 1. Ensure all finding codes with variables/modifiers are populated correctly on the report screen. Do not leave any FitB Modifier Code Fields Blank. 2. Verify report statements match the selections in the work area before finalizing report. Systems may continue to be used in accordance with the intended use and per the additional instructions. The provided recall notification is to be shared with all users of the device and retained with affected systems until the corrected software is installed. The provided recall response form should be returned within 30 days to Philips.recall@Philips.com. A Philips representative will call consignees to schedule a time to install the software solution (FCO83000218). Consignees with any questions can contact Philips Informatics Customer Support at 1-800-996-1328 (x1).
Quantity in Commerce4 units
DistributionUS Nationwide distribution in the states of GA, NC & TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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