Zoe Medical Incorporated Recalls
FDA
Showing 1-2 of 2 recalls
Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.
Unit fails to power up, resulting in an equipment alarm
The firm, Zoe Medical, coordinated with the Distributor via email on June 7, 2012. The email described the product, problem and actions to be taken. Zoe will remove product the site and return the units for correction. If you have any questions, contact Manager, Global Technical Support at 425-657-7200 ext 5508.
The Well@Home Monitor by Patient Care technologies Model 179-2150 Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis.
Touch panel may become unresponsive.
Zoe Medical notified the 2 distributors by e-mail on January 26, 2009 and Feb 6, 2009 of the recall, requesting return of the units for correction.