FDA Issues Recall for Spacelabs Multi-parameter Command Module

Source: FDA · United States

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The FDA has announced a recall of 1790 units of Spacelabs Healthcare's Multi-parameter Command Module due to potential inaccurate cardiac output measurements that could lead to delayed care.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 23, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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FDA Recall of Spacelabs Multi-parameter Command Module

What Happened

Spacelabs Healthcare, Inc. is recalling the Multi-parameter Command Module because of a circuit board issue. This issue may cause Cardiac Output (CO) measurement to activate early in Auto mode, resulting in errors that lead to inaccurate readings or the need for additional readings, potentially causing delayed care and/or fluid overload.

Which Products Are Affected

The affected products are the Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor. A total of 1790 units are involved, with specific serial numbers listed in the recall notice. The units have UDI-DI codes: 10841522106415 and 10841522106422. These products were distributed nationwide in the United States, including states such as 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, and PR, as well as internationally to countries including TAIWAN, CANADA, KUWAIT, FRANCE, SAUDI ARABIA, POLAND, PAKISTAN, MEXICO, ARGENTINA, and PANAMA.

What You Should Do

Consumers and healthcare providers who have the affected products should contact Spacelabs Healthcare, Inc. for instructions, as the recall was initiated via letter. For returns or refunds, reach out to the recalling firm at their address: 35301 Se Center St, Snoqualmie, WA 98065-9216.

Why This Matters

This recall addresses potential risks from inaccurate medical measurements, which could result in delayed patient care or fluid overload, impacting patient safety in healthcare settings.

Source

This information is from the FDA recall notice, recall number Z-1793-2026. For more details, visit the FDA website at https://www.fda.gov/medical-devices/medical-device-recalls/.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
The FDA has announced a recall of 1790 units of Spacelabs Healthcare's Multi-parameter Command Module due to potential inaccurate cardiac output measurements that could lead to delayed care.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.