Recall Z-0969-04 ยท CBN Apparatus, Gas-Scavenging
Datex-Ohmeda Inc
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine, in a Magnetic Reasonance Suite.
| Date | Jul 20, 2004 (initiated Apr 16, 2004) |
| Status | Terminated |
| Reason | Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System. |
| Root cause | Other |
| Action | Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit. |
| Quantity | 10 units |
| Distribution | The affected units were distributed nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993410 | DATES-OHMEDA AESTIVA SMARTVENT MRI Datex-Ohmeda, Inc., Apr 25, 2000 |