CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report
Qube Compact Monitor recalled by Spacelabs Healthcare
Spacelabs Healthcare is recalling Qube Compact Monitor, distributed in 35 states. The recall was initiated on 6 Jun 2014 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-1852-2014
- FDA event ID
- 68491
- Recalling firm
- Spacelabs Healthcare, Snoqualmie, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jun 2014
- FDA classified
- 23 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 6 Jun 2014 | Recall initiated by company | |
| 23 Jun 2014 | Classified by FDA | +17 days |
| 2 Jul 2014 | 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 is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.
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 Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.
Where it was distributed
Worldwide Distribution -- USA, including the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and, the countries of AFG,ARE, ARG, AUS, BHR, BOL, CAN, CHE, CHL, CHN, COL, CRI, DEU, DOM, ECU, FRA, GBR, IND, ITA, JOR, KWT, LBY, MYS, NLD, OMN, PAN, POL, PRT, ROU, SAU, SGP, THA, TTO, TUN, TUR, TWN, and VNM.
AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaineMichiganMinnesotaMissouriMississippiMontana
Questions about this recall
Why was it recalled?
Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.
Which lots are affected?
n/a
Where was it sold?
Worldwide Distribution -- USA, including the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and, the countries of AFG,ARE, ARG, AUS, BHR, BOL, CAN, CHE, CHL, CHN, COL, CRI, DEU, DOM, ECU, FRA, GBR, IND, ITA, JOR, KWT, LBY, MYS, NLD, OMN, PAN, POL, PRT, ROU, SAU, SGP, THA, TTO, TUN, TUR, TWN, and VNM.
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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