Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of anesthetic breathing gas and man
FDA device recall Z-1634-2009 · posted 2009-07-30 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety.
- Action taken
- A GE Healthcare "Urgent Medical Device Correction" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 2,087
- Distribution
- USA including states of AL, AK, AZ, AR, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, and WI and c
- Date initiated
- 2008-10-30
- Date posted
- 2009-07-30
- Date terminated
- 2012-05-17
- Location
- Wauwatosa, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) (K050676) | Datex-Ohmeda, Inc. | 2005-04-12 |
| GE DATEX-OHMEDA AISYS CARESTATION (K042154) | Datex-Ohmeda, Inc. | 2004-08-31 |
| AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) (K973985) | Datex-Engstrom, Inc. | 1998-10-30 |