Z-0857-06

Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)

Name: Z-0857-06 Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)
Creator: GE Healthcare
Published: 2005-11-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-11-16 / Terminated

FDA source

GE Healthcare began a recall of Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) on 2005-11-16. The reason FDA records is "Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or disappear as a result of normal handling of the anesthesia machine...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0857-06
Status: Terminated
Initiated: 2005-11-16
Posted: 2006-05-09
Terminated: 2007-01-23
Recalling firm: GE Healthcare
Product: Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or disappear as a result of normal handling of the anesthesia machine. Visual alarms on the ADU are unaffected by this condition. The dampening or absence of audible alarms on the ADU may result in a delay in treatment.
FDA root cause: Other
Action: Customers were sent a letter dated November 16, 2005, informing them of the possible alarm failure and giving them short term and long term solutions. Short term, clinicians are to: 1) check the audio alarm prior to use; and 2) use the ADU in conjunction with functioning anesthetic agent monitor. In the long term a GE Healthcare representative will contact the facility and schedule a visit to implement the corrective action at no charge.
Quantity in commerce: 113---(USA-61--International-52)
Distribution: Worldwide---USA-States of AZ, CA, IA, MI, TX, and WI ----International- Australia, Austria, Belgium, Finland, Germany, Israel, Italy, Jordan, Malaysia, Netherlands, Norway, Portugal, Slovakia, South Africa, and Turkey.
Product codes and lots: 6025108 thru 6025111, 6025114 thru 6025117, 6025119, 6025120, 6025122 thru 6025128, 6025130 thru 6025132, 6025134, 6025136, 6025137, 6035737, 6035738, 6035740 thru 6035745, 6035747, 6035751, 6035757, 6035758, 6035760, 6035762, 6035765, 6035772 thru 6035774, 6035784, 6048756 thru 6048761, 6048764, 6048847, 6048849, 6048853 thru 6048856 and 40300736

Product code BSZ

K973985Class IIAs/3 Anaesthesia Delivery Unit (As/3 Adu)Datex-Engstrom, Inc. / cleared 1998-10-30

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)