Recall Z-1425-2009 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare
GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.
| Date | Jun 23, 2009 (initiated Feb 5, 2009) |
| Status | Terminated |
| Reason | Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch. If the clinician does not intervene, the patient could experience hypoventilation leading to h |
| Root cause | Component design/selection |
| Action | GE Healthcare contacted consignees via two "Urgent Medical device Correction" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the |
| Quantity | 3082 |
| Distribution | Worldwide distribution: USA, Canada, Mexico, YEMEN, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TUrKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, PERU, PANAMA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073707 | GE DATEX-OHMEDA AISYS Datex-Ohmeda, Inc., Jan 30, 2008 |