Reported Sep 26, 2012 · Terminated

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

Zoe Medical Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zoe Medical Incorporated · 460 Boston St · Topsfield, MA · 01983-1223

Is this the product you have?

  • Spacelabs
  • Ultraview DM3 Monitor Model Number91330-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
Lot codes and dates
  • 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
Amount recalled
35 units

Where it was sold

  • Nationwide
  • WA

Why it was recalled

Unit fails to power up, resulting in an equipment alarm

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 18, 2012 · Data as of Sep 19, 5:24 PM UTC

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