Recall Z-0857-06 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare
Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)
| Date | May 9, 2006 (initiated Nov 16, 2005) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973985 | AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) Datex-Engstrom, Inc., Oct 30, 1998 |