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U.S. Department of Health and Human Services

Class 2 Device Recall Apollo Anesthesia Machine

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  Class 2 Device Recall Apollo Anesthesia Machine see related information
Date Initiated by Firm August 22, 2008
Date Posted October 08, 2008
Recall Status1 Terminated 3 on September 01, 2009
Recall Number Z-0087-2009
Recall Event ID 49442
510(K)Number K042607  
Product Classification Anesthesia Machine - Product Code BSZ
Product Draeger Medical Apollo Anesthesia Machine, catalog number 8606500
Code Information Catalog number 8606500. Serial numbers ARZC-0142, ARZC-0143, ARZC-0144, ARZC-0145, ARZC-0146, ARZC-0147, ARZC-0148, ARZC-0149, ARZC-0150, ARZC-0151, ARZC-0152, ARZC-0153, ARZC-0172, ARZC-0173, ARZC-0174, ARZC-0175, ARZC-0176, ARZC-0177, ARZC-0192, ARZC-0193,ARZC-0196, ARZC-0197, ARZC-0198, ARZC-0199, ARZC-0200, ARZD-0001, ARZD-0002, ARZD-0003, ARZD-0010, ARZD-0011, ARZD-0012, ARZD-0013, ARZD-0014, ARZD-0015, ARZD-0016, ARZD-0017, ARZD-0018, ARZD-0019, ARZD-0020, ARZD-0021, ARZD-0022, ARZD-0023, ARZD-0024, ARZD-0025, ARZD-0026, ARZD-0027, ARZD-0028, ARZD-0029, ARZD-0030, ARZD-0031, ARZD-0032, ARZD-0033, ARZD-0034, ARZD-0035, ARZD-0036, ARZD-0037, ARZD-0038, ARZD-0039, ARZD-0040, ARZD-0041, ARZD-0042, ARZD-0043, ARZD-0044, ARZD-0058, ARZD-0059, ARZD-0060, ARZD-0061, ARZD-0062, ARZD-0063, ARZD-0064, ARZD-0065, ARZD-0066, ARZD-0067, ARZD-0068, ARZD-0069, ARZD-0070, ARZD-0071, ARZD-0072, ARZD-0073, ARZD-0074, ARZD-0075, ARZD-0076, ARZD-0077, ARZD-0078, ARZD-0079, ARZD-0080, ARZD-0081, ARZD-0082, ARZD-0083, ARZD-0084, ARZD-0085, ARZD-0086, ARZD-0087, ARZD-0117, ARZD-0118, ARZD-0119, ARZD-0120, ARZD-0121, ARZD-0122, ARZD-0125, ARZD-0126, ARZD-0127, ARZD-0128, ARZD-0129, ARZD-0130, ARZD-0131, ARZD-0132, ARZD-0133, ARZD-0134, ARZD-0135, ARZD-0136, ARZD-0183, ARZD-0184, ARZD-0185, ARZD-0186, ARZD-0187, ARZD-0188, ARZD-0189, ARZD-0190, ARZD-0191, ARZD-0192, ARZD-0193, ARZD-0194, ARZD-0195, ARZD-0196, ARZD-0197, ARZD-0198, ARZD-0199, ARZD-0200, ARZD-0201, ARZD-0202, ARZD-0203, ARZD-0255, ARZD-0256, ARZD-0257, ARZD-0258, ARZD-0259, ARZD-0260, ARZD-0261, ARZD-0262, ARZD-0263, ARZD-0264, ARZD-0265, ARZD-0266, ARZD-0267, ARZD-0268, ARZD-0269, ARZD-0270, ARZD-0271, ARZE-0001, ARZE-0002, ARZE-0003, ARZE-0004, ARZE-0005, ARZE-0008, ARZE-0009, ARZE-0010, ARZE-0023, ARZE-0024, ARZE-0025, ARZE-0026, ARZE-0027, ARZE-0028, ARZE-0029, ARZE-0030, ARZE-0059, ARZE-0060, ARZE-0061, ARZE-0062, ARZE-0063, ARZE-0064, ARZE-0065, ARZE-0115, ARZE-0116, ARZE-0173, ARZE-0174, ARZE-0175, ARZE-0176, ARZE-0189, ARZE-0190, ARZE-0191, ARZE-0192, ARZE-0193, ARZE-0194, ARZE-0195, ARZE-0196, ARZE-0197, ARZE-0198, ARZE-0199, ARZE-0200, ARZE-0201, ARZE-0202, ARZE-0203, ARZE-0204, ARZE-0214, ARZE-0215, ARZE-0216, ARZF-0011, ARZF-0012, ARZF-0013, ARZF-0014, ARZF-0015, ARZF-0016, ARZF-0017, ARZF-0018, ARZF-0019, ARZF-0020, ARZF-0021, ARZF-0022, ARZF-0023, ARZF-0024, ARZF-0025, ARZF-0026, ARZF-0027, ARZF-0028, ARZF-0029, ARZF-0030, ARZF-0031, ARZF-0084, ARZF-0087, ARZF-0088, ARZF-0089, ARZF-0090, ARZF-0091, ARZF-0092, ARZF-0093, ARZF-0094, ARZF-0095, ARZF-0096, ARZF-0097, ARZF-0098, ARZF-0099, ARZF-0100, ARZF-0101, ARZF-0102, ARZF-0103, ARZF-0104, ARZF-0105, ARZF-0106, ARZF-0107, ARZF-0108, ARZF-0109, ARZF-0110, and ARZF-0111.
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Technical Support
800-543-5047
Manufacturer Reason
for Recall		 Sporadic errors in various device functions, including low readings of the single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical ventilation failure. Alarms and error messages function as designed.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Draeger Medical sent a Medical Device Recall letter to their customers via certified mail on 8/22/08 informing them of the problem. Until the exchange of affected printed circuit boards has been implemented, the firm is recommending that users closely monitor all device displays and error messages and if applicable act in accordance with the advisory statements and remedial information provided in the Instructions for Use as well as making provisions for alternative patient care measures.
Quantity in Commerce 214 units
Distribution Nationwide Distribution.
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, INC.
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