FDA recall Z-2306-2026

GE Medical Systems China Co., Ltd. · Class II · device

Product

MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

Reason for recall

Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.

Distribution

Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.

Key facts

Status: Ongoing
Initiation date: 2026-04-21
Report date: 2026-06-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wuxi, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2306-2026