Hemodynamic Application (mdr)
- Recalling firm
- Philips New Zealand Commercial Limited
- Product
- Hemodynamic Application (MDR). [Device]. Model: Philips Interventional Hemodynamic System; Affected systems are Philips Interventional Hemodynamic Systems with Philips Hemodynamic Application software version 1.4.1 or lower. Also covers: IntelliVue Patient Monitors
- Reason
- The Philips Interventional Hemodynamic System automatically deletes the oldest case data when storage is full, but it does not remove export files, snapshots, or generated reports. These accumulate over time and can eventually fill the Hemo Host PC disk. When the disk is full, new cases cannot be opened - the application launches in review mode only. Live signals from the IntelliVue X3 will still display, but users cannot interact with the data. If the disk becomes full during an active case, data will continue to display and functionality remains, but the case will not be saved and cannot...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-12
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/712b0337-b495-40ad-ba8a-5764c946fd5a