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U.S. Department of Health and Human Services

Class 2 Device Recall Apollo

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  Class 2 Device Recall Apollo see related information
Date Initiated by Firm May 24, 2018
Create Date June 19, 2018
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-2253-2018
Recall Event ID 80209
510(K)Number K081447  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product Apollo Anesthesia Machine; Cat. no. 8605310

Product 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. 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.
Code Information ASKM-0152 ASKN-0138 ASKM-0193 ASKN-0139 ASKM-0202 ASKN-0143 ASKM-0203 ASKN-0144 ASKM-0211 ASKN-0148 ASKM-0212 ASKN-0150 ASKM-0213 ASKN-0151 ASKM-0214 ASKN-0152 ASKM-0221 ASKN-0163 ASKM-0222 ASKN-0164 ASKM-0227 ASKN-0165 ASKM-0228 ASLA-0001 ASKM-0246 ASLA-0002 ASKM-0269 ASLA-0003 ASKM-0272 ASLA-0092 ASKM-0328 ASLA-0121 ASKM-0332 ASLA-0124 ASKM-0333 ASLA-0131 ASKM-0337 ASLA-0132 ASKM-0339 ASLA-0145 ASKM-0340 ASLA-0146 ASKM-0360 ASLA-0152 ASKM-0362 ASLA-0153 ASKM-0366 ASLA-0154 ASKM-0370 ASLA-0163 ASKM-0371 ASLA-0164 ASKM-0408 ASLA-0165 ASKM-0409 ASLA-0166 ASKM-0415 ASLA-0173 ASKN-0012 ASLA-0174 ASKN-0035 ASLA-0175 ASKN-0039 ASLA-0179 ASKN-0040 ASLA-0180 ASKN-0113 ASLA-0181 ASKN-0114 ASLA-0182 ASKN-0116 ASLA-0183 
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact DraegerService Technical Support
800-437-2437
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process change control
Action On May 24, 2018, the firm issued Urgent Medical Device Recall letters to affected end users (medical facilities) via certified mail. The letter identified the affected product, problem and actions to be taken. The recalling firm stated that they are currently manufacturing replacement parts for all potentially affected devices, which will be installed as part of the next service. The firm's Service dept. will contact end users to arrange the replacement Free of Charge In addition, end users were asked to complete and return a Customer Reply Card to acknowledge the receipt of this information. If you have any questions regarding this recall please contact Michael Kelhart between the hours of 8:00 AM  4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DraegerService Technical Support between the hours of 8:00 AM  8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).
Quantity in Commerce 72
Distribution US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DRAEGER MEDICAL AG & CO. KG
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