FDA recall Z-1827-2024

Product

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.

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.

Key facts

Status

Ongoing

Initiation date

2024-04-19

Report date

2024-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1827-2024