Spacelabs Healthcare Recalls qube Compact Monitors for Boot Failure
Spacelabs Healthcare is recalling 2,955 qube Compact Monitors because they may fail to boot up or reset to factory defaults after power on.
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 is classified as FDA Class II, and the defect involves a risk-of-harm product (patient monitor) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Spacelabs Healthcare Inc is recalling the Spacelabs Healthcare qube Compact Monitor, Model 91390. The recall involves a total of 2,955 units, with 2,117 units distributed in the United States and 838 units distributed outside the United States. These monitors function as bedside or central monitors and passively display data generated by Spacelabs Healthcare parameter modules and other SDLC-based products.
The recall was initiated because the firm received multiple reports of the qube monitors failing to boot up or returning to factory default configuration settings following power on or reset. This defect could result in the loss of patient monitoring data or alarm functionality.
Healthcare facilities and consumers should check their serial numbers against the list provided in the official recall notice. Affected units should be removed from service and returned to Spacelabs Healthcare for repair or replacement according to the firm's instructions.
The recalled product
- Product
- Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC
- Manufacturer
- Spacelabs Healthcare Inc
- Category
- Medical Device — Patient Monitor
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 OF UNITS IN THE US: 1390104904
- 1390104905
- 1390-000420
- 1390-000491
- 1390-000528
- 1390-000531
- 1390-000532
- 1390-000767
- 1390-000938
- 1390-001081
- 1390-001346
- 1390-001351
- 1390-100374
- 1390-100556
- 1390-100623
- 1390-100627
- 1390-100628
- 1390-100629
- 1390-100630
- 1390-100632
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Spacelabs Healthcare Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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