Reported Jun 27, 2018 · Terminated
Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo…
Draeger Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Apollo Anesthesia Machine; Cat. no. 8605310
- Product UsageIndicated 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. It is an inhalation anesthesia machine for use in operating, induction, and recovery rooms. It can be used with rebreathing systems, semiclosed to virtually closed systems with low flow and minimal flow techniques, and non-rebreathing systems (with the Auxiliary Common Gas Outlet). It may be used with O2, N2O, and Air supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine. The Apollo is equipped with a compact breathing system, providing fresh-gas decoupling, PEEP, and pressure limitation. It has an electrically driven and electronically controlled ventilator
- Lot codes and dates
72 of 72 codes
ASKM-0152ASKN-0138ASKM-0193ASKN-0139ASKM-0202ASKN-0143ASKM-0203ASKN-0144ASKM-0211ASKN-0148ASKM-0212ASKN-0150ASKM-0213ASKN-0151ASKM-0214ASKN-0152ASKM-0221ASKN-0163ASKM-0222ASKN-0164ASKM-0227ASKN-0165ASKM-0228ASLA-0001ASKM-0246ASLA-0002ASKM-0269ASLA-0003ASKM-0272ASLA-0092ASKM-0328ASLA-0121ASKM-0332ASLA-0124ASKM-0333ASLA-0131ASKM-0337ASLA-0132ASKM-0339ASLA-0145ASKM-0340ASLA-0146ASKM-0360ASLA-0152ASKM-0362ASLA-0153ASKM-0366ASLA-0154ASKM-0370ASLA-0163ASKM-0371ASLA-0164ASKM-0408ASLA-0165ASKM-0409ASLA-0166ASKM-0415ASLA-0173ASKN-0012ASLA-0174
- Amount recalled
- 72
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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