Recall Z-2543-2025 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular, Software 8.0.0.4.
| Date | Sep 9, 2025 (initiated Aug 8, 2025) |
| Status | Open, Classified |
| Reason | Software issue that results in the display of outdated information. |
| Root cause | Software design |
| Action | An 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 a |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of GA, NC & TX. |
| 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 |