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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 January 04, 2011
Date Posted May 10, 2011
Recall Status1 Terminated 3 on March 07, 2013
Recall Number Z-2168-2011
Recall Event ID 57594
510(K)Number K091459  K080652  K092217  
Product Philips FloTrak Elite modules:
FloTrak Elite P/N 1044971
FloTrak Elite P/N 1051005

NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations.
Code Information Serial Numbers: 167-000475 167-000496 175 235 236 237 238 239 240 356 376 389 414 483 502 510 511 686 693 700 723 724 725 612 146 155 171 173 and 178 
Recalling Firm/
Manufacturer		 Respironics Novametrix, LLC.
5 Technology Dr
Wallingford CT 06492-1942
For Additional Information Contact Tood M. Couture
203-697-6348
Manufacturer Reason
for Recall		 Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual.
FDA Determined
Cause 2		 Software design
Action Respironics issued Field Action Notification Letter via Fed'x on 1/4/11, notifying customers of the issue and to instruct them on conditions for continued use and return of the device. The device will be updated with revised software to correct the calculation errors. Any questions or need additional information about this recall action, Contact Respironics US Customer Service at 1-800-345-6443 for customers residing in the USA or +011 (203)697-6488 for International customers.
Quantity in Commerce 38 units
Distribution Nationwide Foreign: Belgium, China, Columbia, Egypt, England, India, Italy, Saudi Arabia, and Spain
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 = and Original Applicant = RESPIRONICS NOVAMETRIX LLC
510(K)s with Product Code = and Original Applicant = RESPIRONICS NOVAMETRIX, INC.
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