Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)
FDA device recall Z-0857-06 · posted 2006-05-09 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 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 A
- Date initiated
- 2005-11-16
- Date posted
- 2006-05-09
- Date terminated
- 2007-01-23
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) (K973985) | Datex-Engstrom, Inc. | 1998-10-30 |