The FDA has posted 7 enforcement recalls from Spacelabs Healthcare, Inc. since 2025, none of them Class I (most serious). Most recent report: May 13, 2026.
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO mea…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of anot…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of anot…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of anot…
Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring.…
Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring.…
Firm name as filed with the FDA: “Spacelabs Healthcare, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.