Z-2077-2014Class II

Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of...

Name: Z-2077-2014 Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of...
Creator: Spacelabs Healthcare Inc
Published: 2014-06-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-06-18 / Terminated / root cause: manufacturing process

FDA source

Spacelabs Healthcare Inc began a recall of 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... on 2014-06-18. FDA classified it as Class II and gives the reason as "With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2077-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-18
Posted: 2014-07-17
Terminated: 2014-12-08
Recalling firm: GE Healthcare
Product: 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.
Product code: CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Reason for recall: With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Spacelabs sent an Urgent Medical Device Correction letter dated June 20, 20/14 to all affected customers. The letter identified the affected product, problem and the actions to be taken. Customers are informed that Spacelabs Field Service personnel will be contacting their facility to schedule a convenient time to confirm, at no cost, a software update is needed to resolve this issue. Customers with questions are instructed to contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.
Quantity in commerce: 8 units total (3 units in US)
Distribution: Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.
Product codes and lots: Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2077-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2077-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-17

Product code CBR

K112173Class IISpeacelabs Multigas ModuleSpacelabs Healthcare / cleared 2011-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)