Spacelabs Healthcare, Inc. is recalling 57 SL Command Modules (Model 91496) because of a manufacturing defect involving a malfunctioning electrical leakage tester. These modules are the core of Spacelabs patient monitoring systems used in hospitals to process physiologic parameters. The company has initiated this voluntary recall by letter to notify affected healthcare facilities. Consumers and healthcare providers should contact Spacelabs Healthcare to arrange for the return, replacement, or correction of the device.
A malfunction in the electrical leakage tester during manufacturing may have allowed modules to pass safety checks despite having potential electrical issues. This could lead to electrical leakage, potentially posing a safety risk to patients or clinical staff during use.
The Command Module inserts into the side of a Spacelabs patient monitor.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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