CLASS II Device recall · Reported 25 Jul 2012 · FDA Enforcement Report
Spacelabs Medical Xprezzon Bedside Monitor recalled
Spacelabs Healthcare is recalling Spacelabs Medical Xprezzon Bedside Monitor, distributed in Florida, Iowa, Oklahoma. The recall was initiated on 12 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2019-2012
- FDA event ID
- 62437
- Recalling firm
- Spacelabs Healthcare, Issaquah, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2012
- FDA classified
- 16 Jul 2012
- Reported
- 25 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 12 Jun 2012 | Recall initiated by company | |
| 16 Jul 2012 | Classified by FDA | +34 days |
| 25 Jul 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
Where it was distributed
Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
040-1632-00; 1393-000013; 1393-000039; 1393-000040; 1393-000041; 1393-000341; 1393-000382; 1393-000383; 1393-000384; 1393-000385; 1393-000386; 1393-000387; 1393-000388; 1393-000808; 1393-000831; 1393-001374; 1393-001375; 1393-001453; 1393-001990; 1393-001991; and 1393-001992.
Where was it sold?
Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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