Recall Z-0968-04 ยท CBN Apparatus, Gas-Scavenging
Datex-Ohmeda Inc
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.
| 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 | 73 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
| K000706 | DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR Datex-Ohmeda, Inc., May 11, 2000 |