Date Initiated by Firm |
June 18, 2014 |
Date Posted |
July 17, 2014 |
Recall Status1 |
Terminated 3 on December 08, 2014 |
Recall Number |
Z-2077-2014 |
Recall Event ID |
68611 |
510(K)Number |
K112173
|
Product Classification |
Analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) - Product Code CBR
|
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. |
Code Information |
Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209 |
Recalling Firm/ Manufacturer |
Spacelabs Healthcare Inc 35301 SE Center St Snoqualmie WA 98065-9216
|
For Additional Information Contact |
800-522-7025 Ext. 2
|
Manufacturer Reason for Recall |
With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = CBR and Original Applicant = SPACELABS HEALTHCARE
|