Recall Z-0544-2021— Philips North America Llc
Class II · Terminated
Class II FDA medical device recall by Philips North America Llc, initiated 2020-11-18, terminated 2021-07-22. It names one FDA 510(k) clearance: K082633. Product: Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.. Reason: Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-18
- Terminated
- 2021-07-22
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.
Reason for recall
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.