Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhal
FDA device recall Z-1443-2013 · posted 2013-06-03 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2 absorbent canisters accessories may not seal properly.
- Action taken
- GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter April 30, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Fax back form was included with the letter requesting the consignees to complete and return.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 800
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, CT, ID, MK, MI, NJ, NY, OH, TN, TX, and VA, and the countries of INDIA, AUSTRALIA, BAHRAIN, BANGLADESH, BOLIVIA, BOSNIA & HE
- Date initiated
- 2013-05-14
- Date posted
- 2013-06-03
- Date terminated
- 2014-03-12
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE DATEX-OHMEDA AVANCE CS2 (K123125) | Datex-Ohmeda, Inc. | 2013-02-06 |
| AESPIRE 7900, AESPIRE VIEW (K122445) | Datex-Ohmeda | 2012-10-12 |
| GE DATEX-OHMEDA AVANCE (K112722) | Datex-Ohmeda, Inc. | 2011-12-16 |
| GE DATEX-OHMEDA AISYS (K110213) | Datex-Ohmeda, Inc. | 2011-07-20 |
| GE DATEX-OHMEDA S/5 ADU CARESTATION (K090892) | GE Healthcare Finland Oy | 2009-04-30 |