Spacelabs Healthcare, Inc. is recalling 1,790 Multi-parameter Command Modules (Model 91496) because a circuit board issue can cause cardiac output measurements to activate too early. This defect may result in errors or inaccurate heart monitoring readings, potentially leading to delayed medical care or fluid overload. These modules were distributed worldwide to various medical facilities and were optioned with either Masimo or Nellcor technology.
The device's circuit board defect causes the cardiac output measurement to trigger prematurely in 'Auto' mode, resulting in incorrect data or the failure to automatically exclude irregular readings. This creates a significant risk that clinicians may make treatment decisions based on inaccurate data, such as administering too much fluid to a patient.
Modules may be optioned with Masimo or Nellcor technology.
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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