FDA Device recall Z-1144-2015
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393 by Spacelabs Healthcare, citing spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to fa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1144-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-28 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spacelabs Healthcare |
| Distribution | n/a |
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 and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
Reason
Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or reset.
Identifiers
| code_info | SERIAL NUMBERS OF UNITS IN THE US: 1390-000197, 1393-000024, 1393-000166, 1393-000199, 1393-003451, 1393-003970, 139…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, 1393-006842, 1393-006844, 1393-006845, 1393-006846, 1393-006847, 1393-006976, 1393-006977, 1393-006978, 1393-006979, 1393-006980, 1393-006981, 1393-006982, 1393-006983, 1393-006984, 1393-006985, 1393-006986, 1393-006987, 1393-007017, 1393-007020, 1393-007021, 1393-007022, 1393-007024, 1393-007025, 1393-007026, 1393-007027, 1393-007028, 1393-007029, 1393-007030, 1393-007031, 1393-007032, 1393-007033, 1393-007034, 1393-007035, 1393-007036, 1393-007037, 1393-007038, 1393-007039, 1393-007040, 1393-007041, 1393-007042, 1393-007043, 1393-007044, 1393-007045, 1393-007046, 1393-007047, 1393-007048, 1393-007049, 1393-007050, 1393-007051, 1393-007052, 1393-007053, 1393-007054, 1393-007055, 1393-007056, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Spacelabs Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1144-2015%22
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