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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 FirmApril 07, 2025
Date PostedMay 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1740-2025
Recall Event ID 96377
510(K)NumberK153022 
Product Classification System, image processing, radiological - Product Code LLZ
ProductIntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Code Information Model Number: 830089; Software Versions: 6x, 7.x, and 8.x; UDI-DIs: (01)00884838106970(11)211130(10)6.1.0.0 (Version 6.1.0.0), (01)00884838106970(11)220623(10)6.2.0.0 (Version 6.2.0.0), (01)00884838115378(11)221214(10)7.0.0.0 (Version 7.0.0.0), (01)00884838115378(11)230711(10)7.1.0.0 (Version 7.1.0.0), (01)00884838122000(11)240325(10)8.0.0.0 (Version 8.0.0.0).
FEI Number 3000976525
Recalling Firm/
Manufacturer		 Philips Medical Systems Nederland B.V.
High Tech Campus 36
Eindhoven Netherlands
For Additional Information ContactInformatics Customer Support
1-800-6691328
Manufacturer Reason
for Recall		An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
FDA Determined
Cause 2		Software in the Use Environment
ActionOn April 7, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 1. Actions that should be taken by the customer / user in order to prevent risks for patients or users " Verify that text added into the report conclusion matches the data in the work area interpret sheet (Refer to Attachment A Screenshot 2) " You may continue to use your system(s) in accordance with the intended use and by following the recommendation above. " Circulate this notice to all users of this device so that they are aware of the potential issue. " Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. " Please review the workflows described in Attachment A and identify whether either workflow is currently in use, or planned to be used, at your facility. Please note your response in the attached customer response form. " If these are not planned to be used at this time, please contact Philips Informatics Customer Support and ensure that this correction is implemented before beginning to use these workflows. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt of this letter via email to: Philips.recall@philips.com. 2. Actions planned by Philips to correct the problem Once all customer responses have been received, a Philips representative will contact customers who use or may use the affected workflows to schedule a time to install the software solution on your system(s) to resolve the issue (reference FCO-TBD). Please be assured that maintaining the highest level of safety and quality is our greatest priority. If you need any further information or support concerning this issue, please contact your local Philips representative: Philips Informatics Customer Support: 1-800-669-1328, Option 1. This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the us
Quantity in Commerce996 units (267 US, 729 OUS)
DistributionDomestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxembourg, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
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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