Zoe Medical Recalls Spacelabs Ultraview DM3 Monitors for Power Failure
Zoe Medical Incorporated is recalling 35 Spacelabs Ultraview DM3 Monitors because they fail to power up, causing equipment alarms.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device failure that could compromise patient monitoring, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zoe Medical Incorporated is recalling 35 units of the Spacelabs Ultraview DM3 Monitor, Model Number 91330-NT. The recall is due to a defect where the unit fails to power up, resulting in an equipment alarm. The device is indicated for use by health care professionals for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including SpO2, pulse rate, NIBP, and temperature.
The affected units were distributed nationwide, specifically in Washington state. The recall covers specific serial numbers ranging from FFD3291 to FFD3817. The source text does not report any illnesses or injuries associated with this defect.
Health care professionals should stop using the affected monitors and contact Zoe Medical Incorporated for instructions on repair or replacement.
The recalled product
- 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
- Manufacturer
- Zoe Medical Incorporated
- Category
- Medical Device — Patient Monitor
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: FFD3291
- FFD3292
- FFD3293
- FFD3294
- FFD3295
- FFD3296
- FFD3297
- FFD3298
- FFD3299
- FFD3300
- FFD3301
- FFD3302
- FFD3303
- FFD3304
- FFD3306
- FFD3307
- FFD3308
- FFD3309
- FFD3310
- FFD3312
Distribution
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