Recall database

Recalls: Software Manufacturing/Software Deployment

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-2306-2026

GE Medical Systems China Co., Ltd. recalls MAC 5 A4 Resting ECG Analysis System 855001-001

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.…

Telephone Electrocardiograph Transmitters And Receivers
Software Manufacturing/Software Deployment

GE Medical Systems Chi…Jun 10, 2026

Class IIOngoingZ-1658-2026

BD KIESTRA LAB AUTOMATION recalls BD Kiestra" ReadA

In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface.…

All Incubators/Water Bath
Software Manufacturing/Software Deployment

BD KIESTRA LAB AUTOMAT…Apr 8, 2026