GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO

FDA device recall Z-0020-2009 · posted 2008-10-06 · Terminated

Recall details

Recalling firm

Datex - Ohmeda, Inc

Reason for recall

The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures.

Action taken

GE Healthcare "Urgent Medical Device Correction" letters dated 8/12/08 were sent on 8/20/08 individually to Health Administrator/Risk Manger, Head of Anesthesia and Director of Clinical Engineering. The letters described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. The Safety Instructions state that the machines can be safely used as long as the following guidelines are followed: 1. Carry out the daily system checkout for any system in use. 2. The Aisys Anesthesia will alert the user both visually and audibly if it detects a fault condition. 3. Have an alternative method of anesthesia available at all times. Once each machine has been corrected an "Update" will be provided by the service technician responsible for the correction. Each customer/machine will receive a "GE Healthcare Urgent Medical Device Correction Update" letter which informs the customer that this correction is a follow-up activity to the letter that was sent earlier.

Root cause

Manufacturing material removal

Status

Terminated

Product code

BSZ

Quantity affected

1571

Distribution

Worldwide Distribution --- USA including states of AL, AK, CA, CO, FL, GA, IL, IN, KS, KY, ME , MD, MA, MI, MO, MT, NE, NV, NH, NY, NC, OH, OK, SC, SD, TX, VA, WV, WI, and DC, and countries of SOUTH A

Date initiated

2008-08-28

Date posted

2008-10-06

Date terminated

2016-03-08

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