Recall Z-2848-2011 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
Vital Signs Devices, a GE Healthcare Company
Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300. The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or
| Date | Jul 30, 2011 (initiated Apr 29, 2011) |
| Status | Terminated |
| Reason | The Hygroscopic Condenser Humidifier (HCH) device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient. |
| Root cause | Device Design |
| Action | An "Urgent Medical Device Correction" letter with the return confirmation form was sent to affected customers. Phone calls were also placed to customers. Consignees were informed of the affected device, issue, and actions to take. Customers were instructed to isolate all affected product, arrange return by contacting Customer Service at 1-800-932-0760, and return only unused product. Customers were asked to complete the attached confirmation form and fax back as per the instructions. For questions, contact your local Vital Signs Account Manager or call Customer service at 1-800-932-0760. |
| Quantity | 222,009 |
| Distribution | Worldwide Distribution including the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.