Recall Z-0006-2008 ยท BSF Absorber, Carbon-Dioxide
Datex - Ohmeda, Inc
GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.
| Date | Oct 4, 2007 (initiated Jul 24, 2007) |
| Status | Terminated |
| Reason | Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module. |
| Root cause | Vendor change control |
| Action | Because this issue only occurs when the Disposable Multi Absorber is used in conjunction with EZchange Module, they have contacted all EZchange Module customers. It is critical to contact these customers specifically, rather than all customers shipped Disposable Multi Absorbers as this may cause unwarranted confusion with customers who do not have the EZchange Module. Consignees were sent an letter dated 7/19/2007 describing the product and problem. The letter lists a number of interim actions to implement with the anesthesia systems. |
| Quantity | 389,070 |
| Distribution | Worldwide, including USA, Australia, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, Estonia, Finland, France, Germany, India, Ireland, Italy, Jordan, Republic of Korea, Kuwait, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Qatar, Singapore, Slovak Republic, South Africa, Spain, Swe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.