Spacelabs Xprezzon Bedside Monitor Recalled for Display Disconnection
Spacelabs Healthcare is recalling 21 Xprezzon Bedside Monitors because specific key presses can cause patient parameters to disappear from the display.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software defect causes patient parameters to disappear from the display, creating a risk of harm due to lack of monitoring, although no injuries or illnesses have been reported.
Plain-English summary
Spacelabs Healthcare, LLC is recalling 21 units of the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. These patient monitors are intended to alert users to alarm conditions and display patient parameters in hospital environments. The recall affects units distributed in the United States (including Florida, Iowa, Oklahoma, and South Carolina) and in India, Germany, and Panama.
The recall was initiated due to reports that a specific combination of key presses can cause the module to disconnect from the monitor. When this occurs, patient parameters drop from the display. The parameters return to the display after the monitor is power cycled.
Healthcare facilities should identify affected units using the provided serial numbers and contact Spacelabs Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- 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…
- Manufacturer
- Spacelabs Healthcare, Llc
- Category
- Medical Device — Patient Monitor
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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