Recall Z-1252-2025 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems Nederland B.V.
Philips IntelliSpace Cardiovascular software, Model 830089.
| Date | Feb 28, 2025 (initiated Apr 4, 2024) |
| Status | Open, Classified |
| Reason | Study data is not able to be archived, copied, or exported with the cardiovascular software version. |
| Root 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 co |
| Quantity | 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. |
| 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 |