Recall Z-1824-2014— Spacelabs Healthcare Inc
Class II · Terminated
Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2014-05-09, terminated 2015-11-16. It names one FDA 510(k) clearance: K903702. Product: Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07. Reason: Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor..
- Recalling firm
- Spacelabs Healthcare Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-09
- Terminated
- 2015-11-16
- 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 Ventilator Flexport Interface, Model 90436A-07
Reason for recall
Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.