Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported

FDA device recall Z-1852-2014 · posted 2014-06-23 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare Inc

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

MHX

Quantity affected

3383 in the USA; 1459 outside the USA

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; a

Date initiated

2014-06-06

Date posted

2014-06-23

Date terminated

2015-02-17

Location

Snoqualmie, WA

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