Recall Z-1198-2018 ยท CAD Vaporizer, Anesthesia, Non-Heated
GE Healthcare, LLC
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.
| Date | Oct 4, 2017 |
| Status | Terminated |
| Reason | Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming. |
| Root cause | Process control |
| Action | The firm, GE healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 4th, 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact GE Service to obtain an RMA number. GE Healthcare has arranged with Piramal Inc. to replace the affected products at no cost. If you have any questions or concern regarding this notification please contact GE healthcare Service at 1-800-437-1171 or your local representative. |
| Quantity | 28 |
| Distribution | US Distribution to states of: AZ, IL NC, NH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012924 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Datex-Ohmeda, Inc., Jan 30, 2002 |