Spacelabs Qube Compact Monitor Recalled for Network Connection Loss
Spacelabs Healthcare is recalling Qube Compact Monitors due to a potential loss of network connection when switching to the Qube Docking Station without powering down.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states that no injuries have occurred and the device's primary alarm functions remain intact, fitting the criteria for a moderate severity issue involving a non-critical defect.
Plain-English summary
Spacelabs Healthcare Inc is recalling the Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection. This issue may occur when switching from a hardwired Ethernet connection to using the Qube Docking Station without powering down the device.
The bedside monitor and all of its alarms will continue to function normally despite the potential network disconnection. No one has been injured as a result of this issue.
The recall affects 3,383 units in the USA and 1,459 units outside the USA. The devices were distributed worldwide, including in numerous US states and countries. Users should be aware of this potential connectivity issue when changing connection methods.
The recalled product
- Product
- Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.
- Manufacturer
- Spacelabs Healthcare Inc
- Category
- Medical Device — Patient Monitor
- Hazard
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 (1)
- n/a
Distribution
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