CompanyDraeger Medical, Inc.
Date of Enforcement Report 6/27/2018
Class lI:
PRODUCT
Apollo Anesthesia Machine; Cat. no. 8605310Product Usage:Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification.
Recall Number: Z-2253-2018
REASON
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc., Telford PA. on 5/24/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
72
DISTRIBUTION
Nationwide
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