Spacelabs SL Command Module patient monitor recall due to manufacturing defect
Spacelabs Healthcare is recalling 57 SL Command Module (Model 91496) patient monitoring devices due to a manufacturing issue with the electrical leakage tester that could affect device safety and performance.
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: This is an FDA Class II recall with no reported illnesses or injuries. The source identifies a manufacturing defect but does not describe a direct hazard of harm; the defect relates to a test equipment malfunction affecting manufacturing quality assurance. Without evidence of actual device failure or patient harm, this meets the Moderate threshold for a Class II recall without reported adverse events.
Plain-English summary
Spacelabs Healthcare, Inc. is recalling the Spacelabs Ultraview SL Command Module (Model 91496), a core component of the Spacelabs patient monitoring system. The recall affects 57 units distributed nationwide in Georgia, Kansas, Michigan, Ohio, South Carolina, Texas, and Washington, as well as Argentina.
The Command Module is being recalled due to a manufacturing issue involving a malfunctioning electrical leakage tester. This defect may impact the proper functioning and safety of the device, which is responsible for processing physiologic parameters in hospital patient monitoring systems.
Patients or healthcare providers who have received one of the affected units should contact Spacelabs Healthcare, Inc. immediately to determine if their specific device is affected and to arrange for appropriate remediation or replacement. Facility staff should verify serial numbers against the list of affected devices and take action as recommended by the manufacturer.
The recalled product
- Product
- Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all b
- Manufacturer
- Spacelabs Healthcare, Inc.
- Hazard
- manufacturing-defect
- electrical-safety
Distribution
Distributed nationwide across the United States.
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