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.
- Company
- Spacelabs Healthcare, Inc.
- Recall Initiated
- June 18, 2014
- Posted
- July 17, 2014
- Terminated
- December 8, 2014
- Recall Number
- Z-2077-2014
- Quantity
- 8 units total (3 units in US)
- Firm Location
- 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.
Lot / Code Info
Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209
Root Cause
Process control
Action Taken
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.