Recall Z-1827-2024— Philips North America Llc

Name: FDA recall Z-1827-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-19

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2024-04-19. It names one FDA 510(k) clearance: K153702. Product: Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.. Reason: Event Catalog information does not save when copied and transferred from one unit to another..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2024-04-19
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K153702 — M3290B Philips IntelliVue Information Center iXPhilips Medical Systems·cleared 2016-06-13

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

Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.

Reason for recall

Event Catalog information does not save when copied and transferred from one unit to another.

Data sourced from openFDA. This site is unofficial and independent of the FDA.