Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)
FDA Recall Z-0857-06 · Posted 2006-05-09
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeBSZ
Date Initiated2005-11-16
Date Terminated2007-01-23
Product Quantity113---(USA-61--International-52)
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.
Firm 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.
Root Cause
Other
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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