Z-0968-04

Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5...

Name: Z-0968-04 Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5...
Creator: Datex-Ohmeda Inc
Published: 2004-04-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-04-16 / Terminated

FDA source

Datex-Ohmeda Inc began a recall of Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine on 2004-04-16. The reason FDA records is "Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0968-04
Status: Terminated
Initiated: 2004-04-16
Posted: 2004-07-20
Terminated: 2005-11-14
Recalling firm: GE Healthcare
Product: Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.
Product code: CBN Apparatus, Gas-Scavenging
Reason for recall: Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
FDA root cause: Other
Action: Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.
Quantity in commerce: 73 units
Distribution: The affected units were distributed nationwide in the United States and worldwide.
Product codes and lots: Serial numbers AMVG01045, AMVG01047, AMVG01052, AMVG01062, AMVG01072 thru AMVG01083, AMVH00100 thru AMVH00109, AMVH00116, AMVH00125, AMVH00126, AMVH00129, AMVH00132, AMVH00133, AMVH00139, AMVH00141 thru AMVH00148, AMVH00151 thru AMVH00154, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00159, AMVH00160, AMVH00164, AMVH00166, AMVH00171 thru AMVH00186, AMVH00195 thru AMVH00198, AMVH00211, and AMVH00228 thru AMVH00230

Product code CBN

K000706Class IIDatex-Ohmeda Aestiva/5 with 7100 VentilatorDatex-Ohmeda, Inc. / cleared 2000-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)