Z-2265-2010

Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds

Name: Z-2265-2010 Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds
Creator: Philips Healthcare Inc.
Published: 2010-07-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-07-21 / Terminated / root cause: design

FDA source

Philips Healthcare Inc. began a recall of Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds on 2010-07-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2265-2010
Status: Terminated
Initiated: 2010-07-21
Posted: 2010-08-24
Terminated: 2012-03-09
Recalling firm: Philips North America LLC
Product: Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: design
FDA root cause: 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: 536 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.
Product codes and lots: Serial Number range 4614H27003 to 4614H28158

Product code BSZ

K040917Class IIPhilips Anesthesia Gas Monitor, Model M1026bPhilips Medizin Systeme Boeblingen GmbH / cleared 2004-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)