ClearanceBrief
Recall Z-0937-03 ยท BSZ Gas-Machine, Anesthesia

Datex-Ohmeda Inc

Datex-Ohmeda S/5 Anesthesia Delivery Units

DateAug 28, 2003 (initiated Jul 15, 2003)
StatusTerminated
ReasonPossible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
Root causeOther
ActionRecall letters dated July 15, 2003 stated that a firm representative would contact the consignees to schedule a visit to replace CPU boards to correct the problem.
Quantity544 units
DistributionThe product was distributed nationwide to hospitals in the Unites States.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K973985AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
Datex-Engstrom, Inc., Oct 30, 1998