Z-2380-2012Class II

Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by...

Name: Z-2380-2012 Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by...
Creator: Zoe Medical Incorporated
Published: 2012-06-06
License: https://open.fda.gov/license/

Zoe Medical, Inc. / initiated 2012-06-06 / Terminated / root cause: software

FDA source

Zoe Medical Incorporated began a recall of Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital... on 2012-06-06. FDA classified it as Class II and gives the reason as "Unit fails to power up, resulting in an equipment alarm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2380-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-06
Posted: 2012-09-14
Terminated: 2012-09-18
Recalling firm: Zoe Medical, Inc.
Product: 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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Unit fails to power up, resulting in an equipment alarm
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 35 units
Distribution: Nationwide distribution: WA only.
Product codes and lots: Serial Numbers: FFD3291, FFD3292, FFD3293, FFD3294, FFD3295, FFD3296, FFD3297, FFD3298, FFD3299, FFD3300, FFD3301, FFD3302, FFD3303, FFD3304, FFD3306, FFD3307, FFD3308, FFD3309, FFD3310, FFD3312, FFD3313, FFD3314, FFD3315, FFD3316,FFD3317, FFD3318, FFD3319, FFD3320, FFD3321, FFD3579, FFD3771, FFD3772, FFD3814, FFD3815, FFD3817

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2380-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2380-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-14

Product code MHX

K093802Class IIUltraview Dm3 MonitorZoe Medical, Inc. / cleared 2010-04-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)