Spacelabs Ultraview DM3 Monitor recallZ-2380-2012 · Zoe Medical Incorporated · initiated Jun 6, 2012
Class II Terminated All recalls posted in September 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zoe Medical Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Unit fails to power up, resulting in an equipment alarm
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2380-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 6, 2012
- Posted by the FDA
- Sep 14, 2012
- Recalling firm
- Zoe Medical Incorporated
- Quantity
- 35 units
- Product code
- MHX
- FDA submissions
- K093802
- Distribution
- Nationwide distribution: WA only.
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
4 devices cleared under K093802 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Ultraview DM3 91330-MZoe Medical Incorporated · Oximeter1 recall0 reports
- Ultraview DM3 91330-MTZoe Medical Incorporated · System, Measurement, Blood-Pressure, Non-Invasive1 recall0 reports
- Ultraview DM3 91330-NZoe Medical Incorporated · System, Measurement, Blood-Pressure, Non-Invasive1 recall0 reports
- Ultraview DM3 91330-NTZoe Medical Incorporated · System, Measurement, Blood-Pressure, Non-Invasive1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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