Product Wiki · Recalls · U.S. FDA — Device Enforcement

Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare paramete — recall Z-2019-2012

U.S. FDA — Device Enforcement · United States · 2012-06-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2019-2012
Date of alert: 2012-06-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Spacelabs Healthcare, Llc
Product category: device
Product type: Devices

Reported risk: There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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