FDA recall Z-1156-2026

Product

Patient Information Center iX; Software Version Number: 4.5.0

Reason for recall

A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.

Distribution

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Canada, Czech Republic, Dominican Rep, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Utd.Arab.Emir.

Key facts

Status

Ongoing

Initiation date

2025-12-22

Report date

2026-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1156-2026