CLASS II Device recall · Reported 27 Nov 2013 · FDA Enforcement Report
qube Compact Patient Monitor recalled by Spacelabs Healthcare
Spacelabs Healthcare is recalling qube Compact Patient Monitor, distributed nationwide in the US. The recall was initiated on 17 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0351-2014
- FDA event ID
- 66727
- Recalling firm
- Spacelabs Healthcare, Snoqualmie, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2013
- FDA classified
- 18 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 17 Oct 2013 | Recall initiated by company | |
| 18 Nov 2013 | Classified by FDA | +32 days |
| 27 Nov 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube 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. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.
Where it was distributed
Worldwide distribution: US (nationwide) including states of: Georgia, Idaho, New York, Oklahoma, Tennessee, Texas, and Wyoming and in countries of: Bahrain, Canada, France, Great Britain, Poland, and The Netherlands.
Nationwide GeorgiaIdahoNew YorkOklahomaTennesseeTexasWyoming
Questions about this recall
Why was it recalled?
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.
Which lots are affected?
SERIAL NUMBERS IN THE US: 1390-101940, 1390-101945, 1390-101946, 1390-101947, 1390-101948, 1390-101950, 1390-101951, 1390-101952, 1390-101953, 1390-101954, 1390-101955, 1390-101956, 1390-101957, 1390-101958, 1390-101962, 1390-101963, 1390-101971, 1390-101972, 1390-101973, 1390-101974, 1390-101979, 1390-101980, 1390-101994, 1390-102002, 1390-102003, 1390-102004, 1390-102005, 1390-102006, 1390-102007, 1390-102008, 1390-102009, 1390-102010, 1390-102011, 1390-102012, 1390-102013, 1390-102014, 1390-102015, 1390-102016, 1390-102017, 1390-102018, 1390-102019, and 1390-102020. SERIAL NUMBER INTERNATIONAL: 1390-101949, 1390-101969, 1390-101970, 1390-101975, 1390-101976, 1390-101977, 1390-101978, 1390-102001, 1390-102021, 1390-102022, 1390-102023, and 1390-102024.
Where was it sold?
Worldwide distribution: US (nationwide) including states of: Georgia, Idaho, New York, Oklahoma, Tennessee, Texas, and Wyoming and in countries of: Bahrain, Canada, France, Great Britain, Poland, and The Netherlands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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