Spacelabs Healthcare Qube Compact Monitor, Model 91390 recallZ-1852-2014 · Spacelabs Healthcare Inc · initiated Jun 6, 2014
Class II Terminated All recalls posted in June 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spacelabs Healthcare Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Component design/selection
What the company is doing
Spacelabs Healthcare Snoqualmie, WA sent an Urgent Medical Device Correction letter, dated June 6, 2014, to all consignees. The letter identified the product, the problem, and the actions to be taken by the customer. The letter instructed customers using docking station ready qube monitors with qube docking stations immediately advise their staff of this situation; and, to follow the steps provided, if they continue to use a docking station ready qube monitor with a docking station. Spacelabs Healthcare will contact customers at the earliest possible date to schedule a convenient time for Spacelabs to correct customer's affected qube monitors at no cost. Questions should be directed to Spacelabs Healthcare Technical Support at 1-800-522-7025.
Recall details
- Recall number
- Z-1852-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 6, 2014
- Posted by the FDA
- Jun 23, 2014
- Recalling firm
- Spacelabs Healthcare Inc
- Quantity
- 3383 in the USA; 1459 outside the USA
- Product code
- MHX
- FDA submissions
- K120616
- Distribution
- 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.
Product description
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.
Code information (models, lots, serial numbers)
n/a
Other devices under the same FDA submission
3 devices cleared under K120616 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Qube Qube Compact MonitorSpacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)3 recalls3 reports
- qube 91390Spacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)21 reports
- qube miniSpacelabs Healthcare (Washington), Inc · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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