Recall Z-3249-2024— Philips North America
Class II · Ongoing
Class II FDA medical device recall by Philips North America, initiated 2024-08-30. It names 2 FDA 510(k) clearances: K131872, K130849. Product: IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066). Reason: During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission..
- Recalling firm
- Philips North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-30
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K131872 — INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
- K130849 — INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)
Reason for recall
During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.
Data sourced from openFDA. This site is unofficial and independent of the FDA.