Spacelabs qube Patient Monitor Recalled for Power-On Failure
Spacelabs Healthcare is recalling 54 qube Compact Patient Monitors because an incorrect microcontroller may prevent the device from powering 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. The hazard involves a critical patient monitoring device failing to power on, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Spacelabs Healthcare, LLC is recalling 54 units of the qube Compact Patient Monitor, Model 91390. The recall involves 42 units in the United States and 12 units distributed internationally in Bahrain, Canada, France, Great Britain, Poland, and The Netherlands.
The recall is due to an incorrect programmed microcontroller component that may cause the monitor to fail to power on. The qube is a patient monitor with arrhythmia detection and alarms intended for use under the direct supervision of a licensed healthcare practitioner or by trained personnel in a hospital environment.
Affected units are identified by specific serial numbers listed in the agency's recall notice. Healthcare facilities should check their inventory for the affected serial numbers and contact Spacelabs Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment
- Manufacturer
- Spacelabs Healthcare, Llc
- 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 (20)
- SERIAL NUMBERS IN THE US: 1390-101940
- 1390-101945
- 1390-101946
- 1390-101947
- 1390-101948
- 1390-101950
- 1390-101951
- 1390-101952
- 1390-101953
- 1390-101954
- 1390-101955
- 1390-101956
- 1390-101957
- 1390-101958
- 1390-101962
- 1390-101963
- 1390-101971
- 1390-101972
- 1390-101973
- 1390-101974
Distribution
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