GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.

FDA device recall Z-1425-2009 · posted 2009-06-23 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

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

Action taken

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 additional 700 units.

Root cause

Component design/selection

Status

Terminated

Product code

BSZ

Quantity affected

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,

Date initiated

2009-02-05

Date posted

2009-06-23

Date terminated

2011-12-10

Location

Wauwatosa, WI

Related 510(k) clearances