FDA Device recall Z-1145-2015
Spacelabs Healthcare qube Compact Monitor, Model 91390
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of Spacelabs Healthcare qube Compact Monitor, Model 91390 by Spacelabs Healthcare, citing spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory de….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1145-2015 |
| 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 qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
Reason
Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube 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: 1390104904, 1390104905, 1390-000420, 1390-000491, 1390-000528, 1390-000531, 1390-…SERIAL NUMBERS OF UNITS IN THE US: 1390104904, 1390104905, 1390-000420, 1390-000491, 1390-000528, 1390-000531, 1390-000532, 1390-000767, 1390-000938, 1390-001081, 1390-001346, 1390-001351, 1390-100374, 1390-100556, 1390-100623, 1390-100627, 1390-100628, 1390-100629, 1390-100630, 1390-100632, 1390-100633, 1390-100634, 1390-100734, 1390-100987, 1390-100991, 1390-101020, 1390-101071, 1390-101301, 1390-101403, 1390-101423, 1390-101577, 1390-101837, 1390-101937, 1390-101945, 1390-101979, 1390-101999, 1390-102042, 1390-102210, 1390-102216, 1390-102320, 1390-102432, 1390-102445, 1390-102446, 1390-102447, 1390-102448, 1390-102449, 1390-102450, 1390-102451, 1390-102452, 1390-102453, 1390-102454, 1390-102455, 1390-102456, 1390-102457, 1390-102458, 1390-102523, 1390-102565, 1390-102566, 1390-102567, 1390-102568, 1390-102569, 1390-102570, 1390-102571, 1390-102572, 1390-102573, 1390-102574, 1390-102575, 1390-102576, 1390-102577, 1390-102578, 1390-102579, 1390-102580, 1390-102581, 1390-102582, 13 |
|---|
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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FDA Device · Class II · 2025-11-12 · Spacelabs Healthcare - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare
All Spacelabs Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1145-2015%22
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