Recall Z-1199-2018 ยท BSZ Gas-Machine, Anesthesia
GE Healthcare, LLC
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
| 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 | 2 |
| 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
| K170872 | Aisys CS2 Datex-Ohmeda, Inc., Aug 15, 2017 |