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RecallWatchMedical Device Safety
Class IIOngoingZ-1793-2026

Spacelabs Healthcare, Inc. recalls Multi-parameter Command Module

Spacelabs Healthcare, Inc.Snoqualmie, WA, United StatesReported Apr 15, 2026 · 3 months ago
Legal News Analyst ·

Reason for recall

Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
    UDI-DI 10841522106415
    400 affected lots
    10841522106415108415221064221496-2237361496-2237371496-2237381496-2243751496-2243761496-224400
    +392 more1496-2244011496-2244021496-2244031496-2244041496-2244051496-2244061496-2238501496-2238511496-2238521496-2244481496-2249561496-2249571496-2249581496-2249591496-2249601496-2249611496-2249811496-2242581496-2235951496-2235961496-2235971496-2235981496-2236191496-2236201496-2236211496-2236221496-2236231496-2236241496-2247171496-2247181496-2238541496-2243731496-2243741496-2238941496-2238951496-2238961496-2238971496-2238981496-2238991496-2239001496-2239011496-2239021496-2239031496-2239041496-2239051496-2239061496-2239071496-2239181496-2250431496-2250441496-2250451496-2250461496-2250471496-2250481496-2250491496-2250501496-2250511496-2250521496-2250531496-2250541496-2250551496-2250561496-2250571496-2250581496-2250591496-2250601496-2250611496-2250621496-2250631496-2250641496-2250651496-2250661496-2250671496-2250681496-2249491496-2237601496-2237611496-2251541496-2246391496-2247191496-2247201496-2247211496-2250881496-2250891496-2246721496-2239081496-2239091496-2239101496-2239111496-2239121496-2239131496-2239141496-2239151496-2239161496-2239171496-2246371496-2246381496-2247521496-2247441496-2247451496-2247461496-2247471496-2244071496-2244081496-2244091496-2244101496-2244111496-2244121496-2244131496-2244141496-2244151496-2244161496-2244171496-2244181496-2244191496-2244201496-2244211496-2247531496-2247541496-2247551496-2247561496-2247571496-2251291496-2238251496-2238261496-2238291496-2238301496-2238311496-2238321496-2238331496-2238341496-2238351496-2238361496-2238371496-2238381496-2238391496-2229281496-2229291496-2237741496-2237751496-2240631496-2240641496-2235801496-2236181496-2233131496-2233141496-2233151496-2233161496-2233171496-2233181496-2233191496-2233201496-2233211496-2233221496-2233231496-2233251496-2233261496-2233271496-2233281496-2233301496-2233311496-2233321496-2233331496-2233341496-2233351496-2233361496-2233371496-2233381496-2233391496-2233401496-2233411496-2233421496-2234191496-2234201496-2234211496-2234221496-2234231496-2234241496-2234251496-2234261496-2234271496-2234281496-2234291496-2234301496-2234311496-2234321496-2234331496-2234341496-2234351496-2234361496-2234371496-2234381496-2234391496-2234401496-2234411496-2234421496-2234431496-2234441496-2234451496-2234461496-2234471496-2234481496-2234491496-2234501496-2234511496-2234521496-2234531496-2234541496-2234551496-2234561496-2234571496-2234581496-2234591496-2234601496-2234611496-2234621496-2234631496-2234641496-2234651496-2234661496-2234671496-2234681496-2234691496-2234701496-2234711496-2234721496-2234731496-2234741496-2234751496-2234761496-2234771496-2234781496-2234791496-2234801496-2234811496-2234821496-2234831496-2234841496-2234851496-2234861496-2234871496-2234881496-2234891496-2234901496-2234911496-2234921496-2234931496-2234941496-2234951496-2234961496-2234971496-2234981496-2234991496-2235001496-2235011496-2235021496-2235031496-2235041496-2235051496-2235061496-2235071496-2235081496-2235091496-2235101496-2235111496-2235121496-2235131496-2235141496-2235151496-2235161496-2235171496-2235181496-2235191496-2235201496-2235211496-2235221496-2235231496-2235241496-2235251496-2235261496-2235271496-2235281496-2235291496-2235301496-2235311496-2235321496-2235331496-2235341496-2235351496-2235361496-2235371496-2235381496-2235391496-2235401496-2235411496-2235421496-2235431496-2235441496-2235451496-2235461496-2235471496-2244271496-2244281496-2244491496-2244501496-2244511496-2244521496-2244531496-2244541496-2244551496-2244561496-2244571496-2244581496-2244591496-2244601496-2244611496-2244621496-2244631496-2244641496-2244651496-2244661496-2244671496-2244681496-2244691496-2244701496-2244711496-2244721496-2244731496-2244741496-2244751496-2244761496-2244771496-2244781496-2244791496-2244801496-2244811496-2244821496-2244831496-2244841496-2244851496-2244861496-2244871496-2244881496-2244891496-2244901496-2244911496-2244921496-2244931496-2244941496-2244951496-2244961496-2244971496-2244981496-2244991496-2245001496-2245011496-2245021496-2245031496-2245041496-2245051496-2245061496-2245071496-2245081496-2245091496-2245101496-2245111496-2245121496-2245131496-2245141496-2245151496-2245161496-2245171496-2245181496-2245191496-2245201496-2245211496-2245221496-2245231496-2245241496-2245251496-2245261496-2245271496-2245281496-2249261496-2249271496-2249281496-2249291496-2249301496-2249311496-2249321496-2249331496-224934

What the firm is doing

On 2/27/2026, correction notices were emailed to customers who were asked to do the following: 1. Notify all relevant employees within your organization. If products were further distributed, please forward the notice to these sites/customers. 2. Complete and return the acknowledgement form via email to: Installedbase@Spacelabs.com 3. Instruct staff who utilize the cardiac output feature to use the "Manual" mode, or use a non-impacted module in its place (if available) until the impacted module has been corrected. 4. Contact your local Spacelabs Healthcare service and support representative to schedule your device correction as soon as possible. Firm's Support Contact: Phone: 1-800-522-7025 Email: Support@Spacelabs.com Website: https://spacelabshealthcare.com/support/

DistributionShow details

Worldwide - US Nationwide distribution including in the states of NY, NJ, AL, OK, IA, MT, WY, MN, TX, WI, PA, WA, OR, MI, CA, SC, ID, FL, MS, KS, SD, LA, OH, MO, NH, GA, MD, TN, AZ, PR and the countries of TAIWAN, CANADA, KUWAIT, FRANCE, SAUDI ARABIA, POLAND, PAKISTAN, MEXICO, ARGENTINA, PANAMA.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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