Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 25, 2012
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.
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 dr…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Spacelabs Healthcare, Llc recalled Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It … - a moderate-severity action.
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It … was recalled by Spacelabs Healthcare, Llc in July 25, 2012. Reason: There were reports that a certain combination of key presses will cause the module to disconnect from the Xpr…. Check the official notice for the remedy. Verify recall #Z-2019-2012 with the FDA Devices before acting.
The recall
Spacelabs Healthcare, Llc issued this moderate-severity FDA Devices recall-There were reports that a certain combination of key presses will cause the module to disconnect from the Xpr….
- Moderate
- severity level
- 21 units
- affected scope
- Class II
- classification
- July 25, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2019-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2019-2012) was formally reported on July 25, 2012, with the manufacturer initiating the action on June 12, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Spacelabs Healthcare, Llc is listed as the recalling firm, operating out of Issaquah, WA. Federal records list the affected scope as 21 units.
The documented reason for this recall is: 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 retu… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
21 units
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2019-2012 |
| Date reported | July 25, 2012 |
| Date initiated | June 12, 2012 |
| Recalling firm | Spacelabs Healthcare, Llc |
| Firm location | Issaquah, WA |
| Affected scope | 21 units |
| Distribution | Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2019-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Spacelabs Healthcare, Llc. Units affected: 21 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2012. Severity: Moderate. Recall number: Z-2019-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2019-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 25, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.