Recall Z-2077-2014 ยท CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Spacelabs Healthcare Inc
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.
| Date | Jul 17, 2014 (initiated Jun 18, 2014) |
| Status | Terminated |
| Reason | With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112173 | SPEACELABS MULTIGAS MODULE Spacelabs Healthcare, Oct 5, 2011 |