Food, drugs, devices › Spacelabs Healthcare, Inc.
Device recall: Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software V
FDA enforcement event 98722 is a device recall by Spacelabs Healthcare, Inc. of Snoqualmie, WA, initiated 26 Mar 2026 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Spacelabs Healthcare, Inc. has 27 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Spacelabs Healthcare, Inc., Snoqualmie, WA.
Reason for recall
"Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester)."
Distribution
"Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2052-2026 | Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command… | 57 | Class II | Ongoing | 13 May 2026 |
Context
Other enforcement events for Spacelabs Healthcare, Inc.
All 27 events for Spacelabs Healthcare, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.