—#93109

Product

Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds

FDA product code: BSZ — Gas-Machine, Anesthesia
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K060541
Affected lot / code info: Serial Number range ARYE-0014 to ASBC-0013

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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..

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-07-21
Posted by FDA: 2010-08-24
Terminated: 2012-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93109. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.