Recall Z-1852-2014— Spacelabs Healthcare Inc
Class II · Terminated
Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2014-06-06, terminated 2015-02-17. It names one FDA 510(k) clearance: K120616. Product: 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.. Reason: 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..
- Recalling firm
- Spacelabs Healthcare Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-06
- Terminated
- 2015-02-17
- Firm location
- Snoqualmie, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.