—#43016

Product

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

FDA product code: BSZ — Gas-Machine, Anesthesia
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K973985
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 3030 Ohmeda Drive PO Box 7550, zip 53707-7550, Madison, Wisconsin 53718

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2005-11-16
Posted by FDA: 2006-05-09
Terminated: 2007-01-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.