Recall Z-0020-2009
Datex - Ohmeda, Inc · initiated August 28, 2008
Product
GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550 Datex-Ohmeda Aisys Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
Codes / lots: Short Number ANAK00225 ANAK00890 ANAK00926 ANAL00101 ANAL00102 ANAL00303 ANAK00284 ANAK00285 ANAK00286 ANAK00287 ANAK00288 ANAK00289 ANAK00290 ANAK00291 ANAK00292 ANAK00293 ANAK00294 ANAK00295 ANAK00296 ANAK00298 ANAK00299 ANAK00300 ANAK00301 ANAK00302 ANAK00303 ANAK00304 ANAK00305 ANAK00306 ANAK00307 ANAK00308 ANAK00309 ANAK00310 ANAK00311 ANAK00312 ANAK00313 ANAK00314 ANAK00315 ANAK00316 ANAK00317 ANAK00318 ANAK00319 ANAK00478 ANAK00479 ANAK00480 ANAK00297 ANAL00411 ANAK00774 ANAK00775 ANAL00490 ANAL00491 ANAL00492 ANAL00493 ANAL00494 ANAL00495 ANAL00496 ANAL00497 ANAL00498 ANAL00499 ANAL00500 ANAL00501 ANAL00315 ANAL00316 ANAL00317 ANAL00318 ANAL00319 ANAL00320 ANAL00321 ANAJ00251 ANAJ00248 ANAK00162 ANAK00163 ANAK00164 ANAK00165 ANAK00166 ANAK00167 ANAK00226 ANAK00227 ANAK00228 ANAK00229 ANAK00230 ANAK00231 ANAK00232 ANAK00233 ANAJ00120 ANAJ00121 ANAJ00125 ANAJ00126 ANAJ00127 ANAJ00128 ANAJ00129 ANAJ00134 ANAJ00135 ANAJ00136 ANAJ00137 ANAL00573 ANAL00574 ANAL00575 ANAL00576 ANAL00577 ANAL00578 ANAL00579 ANAL00580 ANAL00581 ANAL00582 ANAL00583 ANAH00115 ANAJ00100 ANAJ00106 ANAJ00110 ANAJ00200 ANAJ00201 ANAJ00204 ANAJ00214 ANAJ00215 ANAJ00216 ANAJ00217 ANAJ00218 ANAJ00219…
Reason for recall
The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures.
FDA-determined cause: Manufacturing material removal
Action taken
GE Healthcare "Urgent Medical Device Correction" letters dated 8/12/08 were sent on 8/20/08 individually to Health Administrator/Risk Manger, Head of Anesthesia and Director of Clinical Engineering. The letters described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. The Safety Instructions state that the machines can be safely used as long as the following guidelines are followed: 1. Carry out the daily system checkout for any system in use. 2. The Aisys Anesthesia will alert the user both visually and audibly if it detects a fault condition. 3. Have an alternative method of anesthesia available at all times. Once each machine has been corrected an "Update" will be provided by the service technician responsible for the correction. Each customer/machine will receive a "GE Healthcare Urgent Medical Device Correction Update" letter which informs the customer that this correction is a follow-up activity to the letter that was sent earlier.
Details
- Recall number
- Z-0020-2009
- Initiated
- August 28, 2008
- Posted by FDA
- October 6, 2008
- Terminated
- March 8, 2016
- Product code
- BSZ – Gas-Machine, Anesthesia
- Quantity
- 1571
- Distribution
- Worldwide Distribution --- USA including states of AL, AK, CA, CO, FL, GA, IL, IN, KS, KY, ME , MD, MA, MI, MO, MT, NE, NV, NH, NY, NC, OH, OK, SC, SD, TX, VA, WV, WI, and DC, and countries of SOUTH AFRICA, TURKEY, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, QATAR, PORTUGAL POLAND, NEW ZEALAND, NORWAY, NETHERLANDS, MEXICO, LIBYA, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, UNITED KINGDOM, FRANCE…
- Recalling firm
- Datex - Ohmeda, Inc