Food, drugs, devices › Spacelabs Healthcare Inc
Device recall: Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a
FDA enforcement event 68611 is a device recall by Spacelabs Healthcare Inc of Snoqualmie, WA, initiated 18 Jun 2014 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 8 Dec 2014. 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
"With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid."
Distribution
"Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2077-2014 | Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits. | 8 units total (3 units in US) | Class II | Terminated | 23 Jul 2014 |
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: "With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid."
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 Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Dec 2014. "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.