PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 22, 2024 Initiated: April 19, 2024 #Z-1827-2024

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.

Details

Recalling Firm
Philips North America Llc
Units Affected
358 units (US: 45; OUS: 313)
Distribution
Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, MA, MI, MN, MO, NJ, NM, NY, OH, PA, TN, TX, WA, WV, & DC. The countries of AE, AT, AU, BE, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IL, IN, IT, JP, KR, LT, NL, NO, OM, PL, PT, RO, SE, SG, SK, TH, & ZA.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.. Recalled by Philips North America Llc. Units affected: 358 units (US: 45; OUS: 313).
Why was this product recalled?
Event Catalog information does not save when copied and transferred from one unit to another.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1827-2024.