Spacelabs XPREZZON Bedside Monitors Recalled for Boot Failure
Spacelabs Healthcare is recalling XPREZZON Bedside Monitors because they may fail to boot up or reset to factory defaults after power on.
What this means for you
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 is classified as FDA Class II, and the device is a medical monitor where failure to boot or reset to defaults poses a risk of harm to patients, although no specific injuries are reported in the source text.
Plain-English summary
Spacelabs Healthcare Inc is recalling the XPREZZON Bedside Monitor, Model 91393. The recall was initiated after the firm received multiple reports that the monitors failed to boot up or returned to factory default configuration settings following a power on or reset.
A total of 1,578 units are affected by this recall, with 702 units located in the United States and 876 units distributed outside the US. The monitors are used to passively display data generated by Spacelabs parameter modules and other products as waveforms, numeric displays, trends, and alarms.
The source text does not specify instructions for consumers or healthcare facilities on how to proceed with the recall or what to do if they possess an affected unit.
The recalled product
- Product
- Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends a
- Manufacturer
- Spacelabs Healthcare Inc
- Category
- Medical Device — Patient Monitor
- Hazard
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)
- SERIAL NUMBERS OF UNITS IN THE US: 1390-000197
- 1393-000024
- 1393-000166
- 1393-000199
- 1393-003451
- 1393-003970
- 1393-004222
- 1393-004306
- 1393-004319
- 1393-004457
- 1393-004962
- 1393-005365
- 1393-006156
- 1393-006635
- 1393-006636
- 1393-006815
- 1393-006816
- 1393-006839
- 1393-006840
- 1393-006841
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Spacelabs Healthcare Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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