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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraview SL Capnography Module, Model 91517

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  Class 2 Device Recall Ultraview SL Capnography Module, Model 91517 see related information
Date Initiated by Firm July 20, 2005
Date Posted February 16, 2006
Recall Status1 Terminated 3 on February 17, 2006
Recall Number Z-0517-06
Recall Event ID 32815
510(K)Number K031124  
Product Classification Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - Product Code CCK
Product Ultraview SL Capnography Module, Model 91517
A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ventilatory, circulatory, and metabolic status.
Code Information Model 91517 Lot BMP007559 
Recalling Firm/
Manufacturer		 Spacelabs Medical Incorporated
5150 220th Ave Se
Issaquah WA 98029-6834
Manufacturer Reason
for Recall		 The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes.
FDA Determined
Cause 2		 Other
Action On 7/20/05 Spacelabs called the consignees that received the units to notify them of the hazard and also the schedule a service call to repair the affected capnography modules. The firm will confirm that all consignees have been updated with the appropriate PCBA and will audit the device recall records for completion.
Quantity in Commerce 11 units
Distribution 8 units shipped to France, 1 unit to Brussels, Belgium, and 2 units to a medical center in WY.
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 = CCK and Original Applicant = DATEX-OHMEDA, INC.
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