IntelliVue X3 Patient Monitor.
FDA device recall Z-1315-2018 · posted 2018-04-06 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- Reason for recall
- The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.
- Action taken
- Philips will contact customers with affected devices to arrange a correction of the issues. Firm plans a Software update of the affected devices and Replacement of the display assembly.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 975 (updated 8-14-18)
- Distribution
- 48 Foreign Accounts
- Date initiated
- 2017-11-17
- Date posted
- 2018-04-06
- Date terminated
- 2020-09-16
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable (K171801) | Philips Medizin Systeme Boeblingen GmbH | 2017-10-06 |