Recall Z-1740-2025 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
| Date | May 8, 2025 (initiated Apr 7, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software in the Use Environment |
| Action | On 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 s |
| Quantity | 996 units (267 US, 729 OUS) |
| Distribution | Domestic: 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, U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153022 | Philips IntelliSpace Cardiovascular Philips Medical Systems Nethrlands BV, Nov 18, 2015 |