Recall Z-2263-2010 ยท BSZ Gas-Machine, Anesthesia
Philips Healthcare Inc.
Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds
| Date | Aug 24, 2010 (initiated Jul 21, 2010) |
| Status | Terminated |
| Reason | 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 | 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 (Instr |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060541 | THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS Philips Medizin Systeme Boblingen GmbH, Mar 24, 2006 |