Reported Jun 25, 2014 · Terminated

Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07

Spacelabs Healthcare Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Spacelabs Healthcare Inc · 35301 SE Center St · Snoqualmie, WA · 98065-9216

Is this the product you have?

  • Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Lot codes and dates
  • Serial Numbers Distributed in the US
    • 436A000660
    • 436A000663
    • 436A000664
    • 436A000666
    • 436A000667
    • 436A000669
    • 436A004306
    • 436A004307
    • 436A004308
    • 436A004309
    • 436A004310
    • 436A006122
    • 436A006123
    • 436A006441
    • 436A006442
    • 436A006443
    • 436A006444
    • 436A006452
    • 436A006573
    • 436A006589
    • 436A006590
    • 436A006591
    • 436A006592
    • 436A006593
    • 436A006594
    • 436A006595
    • 436A006596
    • 6A006597
    • 436A006598
    • 436A006599
    • 436A006600
    • 436A006601
    • 436A00670
    • 436A006966 436A01020
    • 436A02086
    • 436A02087
    • 436A02088
    • 436A02234
    • 436A02246
    • 436A02247
    • 436A02281
    • 436A02282
    • 436A02283
    • 436A03237 and 436A03238. Serial
  • Numbers Distributed Outside the US

    108 of 108 codes

    • 436A003628
    • 436A003629
    • 436A003630
    • 436A003631
    • 436A003632
    • 436A003633
    • 436A003634
    • 436A003635
    • 436A003636
    • 436A003637
    • 436A003638
    • 436A003639
    • 436A003640
    • 436A003644
    • 436A003645
    • 436A003646
    • 436A003647
    • 436A004162
    • 436A004166
    • 436A004197
    • 436A004198
    • 436a005205
    • 436a005471
    • 436a005472
    • 436A005638
    • 436A005641
    • 436A005642
    • 436A006087
    • 436A006088
    • 436A006151
    • 436A006193
    • 436A006248
    • 436A006249
    • 436A006250
    • 436A006262
    • 436A006389
    • 436A006390
    • 436A006397
    • 436A006445
    • 436A006446
    • 436A006522
    • 436A006523
    • 436A006524
    • 436A006570
    • 436A006571
    • 436A006572
    • 436A006609
    • 436A006610
    • 436A006611
    • 436A006612
    • 436A006613
    • 436A006614
    • 436A006616
    • 436A006617
    • 436A006618
    • 436A006619
    • 436A006620
    • 436A006621
    • 436A006624
    • 436A006625
Amount recalled
46 units distributed within the US; 108 units distributed outside the US.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 16, 2015 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.