Spacelabs Healthcare Inc: Medical Device Recall in 2014 - (Recall #: Z-1852-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: June 6, 2014
Date Posted: July 2, 2014
Recall Number: Z-1852-2014
Event ID: 68491
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.

Status: Terminated
Product Quantity: 3383 in the USA; 1459 outside the USA
Code Information:

n/a

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated