Xhibit Central Station recall — FDA Z-2916-2026
Due to off-the-shelf display port component that has audio/video failures
Overview of recall records associated with Spacelabs Healthcare, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 12.
Due to off-the-shelf display port component that has audio/video failures
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…
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…
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…
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…
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…
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…
Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer…
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery,…
The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
This page summarizes recall records in which the official source identifies Spacelabs Healthcare, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.