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U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare Ultraview SL Multigas Module

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  Class 2 Device Recall Spacelabs Healthcare Ultraview SL Multigas Module see related information
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
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