Spacelabs qube Compact Monitor Recalled for Power Failure Risk
Spacelabs Healthcare is recalling five qube Compact Monitors because the input power can fail or the device may not turn on.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with a risk of harm (power failure) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria.
Plain-English summary
Spacelabs Healthcare Inc is recalling five units of the Spacelabs qube Compact Monitor, Model 91390. These monitors function as bedside or central monitors and passively display data from parameter modules and interfaces.
The recall is due to a defect where the input power can fail even if the wall power source is uninterrupted. Additionally, there is a potential for the monitor to fail to turn on. This is a retrospective recall related to a previous recall initiated in 2012 (Z-0403-2013).
The affected units were distributed in North Carolina, Texas, and Wyoming. The specific serial numbers are 1390-000054, 1390-000064, 1390-000313, 1390-000047, and 1390-000898.
The recalled product
- Product
- Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric…
- Manufacturer
- Spacelabs Healthcare Inc
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 5
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 (5)
- Serial Numbers: 1390-000054
- 1390-000064
- 1390-000313
- 1390-000047
- 1390-000898.
Distribution
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Similar recalls
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