FDA recall Z-2279-2026

GE Medical Systems Information Technologies Inc · Class II · device

Product

CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3

Reason for recall

Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.

Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Bangladesh, Cambodia, Canada, Croatia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Philippines, Poland, Qatar, Romania, Saudi Arabia, Senegal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom.

Key facts

Status
Ongoing
Initiation date
2026-04-24
Report date
2026-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Milwaukee, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2279-2026