SPACELABS HEALTHCARE INC

QUBE · Radiology

510(k): 0 Recall: 3 UDI: 0 MAUDE: 10 Class.: 60

Recalls (3)

Spacelabs qube Compact Monitor, Model 91390. The monitor is 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 al

2015-05-08

The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013).

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

2015-01-28

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.

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.

2014-06-06

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.

MAUDE Adverse Events (10)

Malfunction

20210409

Malfunction

20210323

Malfunction

20201229

Malfunction

20201207

Malfunction

20201104

Malfunction

20201103

Malfunction

20200904

Malfunction

20200720

Death

20200630

Malfunction

20200616

FDA Classification (60)

Processor, Cine Film

Radiology

Hydrogel Spacer

Radiology

Cassette, Measurement, Ardran-Crooks

Radiology

Assembly, Tube Housing, X-Ray, Therapeutic

Radiology

Generator, Orthovoltage, Therapeutic X-Ray

Radiology

Cabinet, X-Ray System

Radiology

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Radiology

Camera, Multi Format, Radiological

Radiology

System, Imaging, Holography, Acoustic

Radiology

Film, Radiographic

Radiology

Counter, Whole Body, Nuclear

Radiology

Holder, Syringe, Lead

Radiology

Processor, Radiographic-Film, Automatic, Dental

Radiology

Camera, X-Ray, Fluorographic, Cine Or Spot

Radiology

System, Therapeutic, X-Ray

Radiology

Display, Diagnostic Radiology

Radiology

Radiation Therapy Marking Device

Radiology

Radiological Computer-Assisted Prioritization Software For Lesions

Radiology

System, Nuclear Magnetic Resonance Imaging

Radiology

Colon Computed Tomography System, Computer Aided Detection

Radiology

Instrument, Quality-Assurance, Radiologic

Radiology

Analyzer, Medical Image

Radiology

Dosimeter, Ionizing Radiation, Implanted

Radiology

Solid State Fluoroscopic X-Ray Imager

Radiology

Processor, Radiographic-Film, Automatic

Radiology

Test-Pattern, Radiographic

Radiology

Densitometer, Bone

Radiology

Image Management Software For Planning Of Otologic And Neurotologic Procedures

Radiology

Radiological Software Device To Predict Future Breast Cancer Risk

Radiology

Device, Beam Limiting, X-Ray, Diagnostic

Radiology

Prostate Immobilizer Rectal Balloon

Radiology

Device, Communications, Images, Ophthalmic

Radiology

System, X-Ray, Mammographic

Radiology

Chair, Pneumoencephalographic

Radiology

Phantom, Anthropomorphic, Radiographic

Radiology

Changer, Radiographic Film/Cassette

Radiology

System, Applicator, Radionuclide, Remote-Controlled

Radiology

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Radiology

Needle, Isotope, Gold, Titanium, Platinum

Radiology

Shield, Gonadal

Radiology

Source, Teletherapy, Radionuclide

Radiology

System, Image Processing, Radiological

Radiology

Arthrogram Tray

Radiology

Tube Mount, X-Ray, Diagnostic

Radiology

Device, Digital Image Storage, Radiological

Radiology

Post Breast Biopsy Hemostatic Breast Compression Device

Radiology

Collimator, Low Voltage, Therapeutic X-Ray

Radiology

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Radiology

Source, Isotope, Sealed, Gold, Titanium, Platinum

Radiology

Table, Radiologic

Radiology

System, Applicator, Radionuclide, Manual

Radiology

Programmer, Changer, Film/Cassette, Radiographic

Radiology

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Radiology

Holder, Radiographic Cassette, Wall-Mounted

Radiology

Radiographic Contrast Tray

Radiology

System, X-Ray, Fluoroscopic, Image-Intensified

Radiology

Automated Radiological Image Processing Software

Radiology

System, Imaging, X-Ray, Electrostatic

Radiology

Coil, Magnetic Resonance, Specialty

Radiology

Device, Spot-Film

Radiology