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U.S. Department of Health and Human Services

Class 2 Device Recall Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds

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 Class 2 Recall
Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds
see related information
Date Posted August 24, 2010
Recall Status1 Terminated on March 09, 2012
Recall Number Z-2263-2010
Recall Event ID 56273
Premarket Notification
510(K) Number
K060541 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds
Code Information Serial Number range ARYE-0014 to ASBC-0013
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer Reason
for Recall
The manifold seal in the Philips M1657B Water Trap used on the Philips M1013A IntelliVue G1, M1019A, IntelliVue G5, and Anesthesia Gas Modules M1026B/BT may be unintentionally removed when changing the traps. A missing seal may result in leakage and may cause incorrect monitor readings of inspiratory or expiratory gas levels.
FDA Determined
Cause 2
DESIGN: Device Design
Action Philips Healthcare issued an "Urgent Device Correction" letter dated July 14, 2010 with an addendum to the Instructions for Use including additional instructions for the replacement of the water trap for the Philips M1013A IntelliVue G1, M1019A IntelliVue G5, M1026B/BT Anesthesia Gas Modules. This addendum is being sent along with the Urgent Medical Device Correction notice to all affected customers. Customers will be requested to incorporate the information contained in the Urgent Medical Device Correction notice and the Addendum to the Instructions for Use with the existing labeling (Instructions for Use) provided with the product. Customers can contact Philips at 1-800-722-9377 for further information..
Quantity in Commerce 531 units
Distribution Worldwide Distribution: United States, and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile ,China ,Colombia, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Latvia, Libyan Arab Jamahiriya, Luxembourg, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Peru, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH
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