Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds
FDA device recall Z-2264-2010 · posted 2010-08-24 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- 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.
- Action taken
- 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..
- Root cause
- Device Design
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 3241 untis
- Distribution
- Worldwide Distribution: United States, and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile ,China ,Colombia, Czech Republic, Estonia, Finland, Fra
- Date initiated
- 2010-07-21
- Date posted
- 2010-08-24
- Date terminated
- 2012-03-09
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS (K060541) | Philips Medizin Systeme Boblingen GmbH | 2006-03-24 |