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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm July 29, 2011
Date Posted September 30, 2011
Recall Status1 Terminated 3 on May 23, 2012
Recall Number Z-3288-2011
Recall Event ID 59312
510(K)Number K091459  K080652  K092217  
Product Classification Spirometer, monitoring (w/wo alarm) - Product Code BZK
Product FloTrak Elite modules
FloTrak Elite P/N 1044971
FloTrak Elite P/N 1051005
Code Information Serial Numbers 525 539 146 155 171 173 178 611 612 150 165 231 234 175 235 236 237 238 239 240 356 376 389 414 000475 483 000496 502 510 511 686 693 700 723 724 725 167-000385 167-000487 232 000372, and 000834. 
Recalling Firm/
Manufacturer		 Respironics Novametrix, LLC.
5 Technology Dr
Wallingford CT 06492-1942
For Additional Information Contact Todd M. Coutire
203-697-6348
Manufacturer Reason
for Recall		 Pressure lines maybe occluded and display incorrect tidal volumes.
FDA Determined
Cause 2		 Manufacturing material removal
Action Respironics Novametrix, LLC on July 29, 2011 notified accounts via e-mail or tracked receipt, an Urgent - Medical Device Recall letter to notify customers of the issue and to instruct them on conditions for continued use. Monitors will need to be returned for functional performance testing at their facility. Customers can contact Respironics US Customer Service at 1-877-387-3311 for customers residing in the USA or +011 (203)697-6348 for International customers, if they have any questions or need additional information.
Quantity in Commerce 41 units
Distribution Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.
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 = BZK and Original Applicant = RESPIRONICS NOVAMETRIX LLC
510(K)s with Product Code = BZK and Original Applicant = RESPIRONICS NOVAMETRIX, INC.
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