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Terminated

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.

FDA Recall Z-2380-2012 · Posted 2012-09-14

Recalling FirmZoe Medical Incorporated
Recall StatusTerminated
Product CodeMHX
Date Initiated2012-06-06
Date Terminated2012-09-18
Product Quantity35 units

Reason for Recall

Unit fails to power up, resulting in an equipment alarm

Firm Action

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.

Root Cause

Software design

Distribution Pattern

Nationwide distribution: WA only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093802ULTRAVIEW DM3 MONITORZoe Medical, Inc. · 2010-04-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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