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U.S. Department of Health and Human Services

Class 2 Device Recall Fabius GS Anesthesia Machine

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 Class 2 Recall
Fabius GS Anesthesia Machine
see related information
Date Posted July 16, 2008
Recall Status1 Terminated on September 09, 2008
Recall Number Z-1315-2008
Recall Event ID 46806
Premarket Notification
510(K) Number
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969.
Code Information Serial Numbers: ARWM0008, ARWM0009, ARWM0010, ARWM0011, ARWM0012, ARWM0013, ARWM0014, ARWM0015, ARWM0029, ARWM0030, ARWM0031, ARWM0032, ARWM0033, ARWM0034, ARWM0035, ARWM0036, ARWM0037, ARWM0050, ARWM0051, ARWM0052, ARWM0053, ARWM0057, ARWM0058, ARWM0059, ARWM0061, ARWM0062, ARWM0063, ARWM0064, ARWM0065, ARWM0066, ARWM0067, ARWM0068, ARWM0069, ARWM0070, ARWM0071, ARWM0072, ARWM0073, ARWM0074, ARWM0075, ARWM0076, ARWM0077, ARWM0078, ARWM0079, ARWM0080, ARWM0081, ARWM0082, ARWM0083, ARWM0084, ARWM0085, ARWM0092, ARWM0093, ARWM0097, ARWM0098, ARWM0099, ARWM0100, ARWM0101, ARWM0102, ARWM0103, ARWM0104, ARWM0105, ARWM0108, ARWM0112, ARWM0113, ARWM0114, ARWM0115, ARWM0116, ARWM0117, ARWM0118, ARWM0119, ARWM0120, ARWM0121, ARWM0122, ARWM0123, ARWM0124, ARWM0125, ARWM0126, ARWM0127, ARWM0128, ARWM0129, ARWM0130, ARWM0131, ARWM0132, ARWM0133, ARWM0134, ARWM0135, ARWM0136, ARWM0137, ARWM0138, ARWM0139, ARWM0140, ARWM0157, ARWM0159, ARWM0160, ARWM0161, ARWM0162, ARWM0163, ARWM0164, ARWM0165, ARWM0167, ARWM0168, ARWM0169, ARWM0170, ARWM0171, ARWM0172, ARWM0176, ARWM0177, ARWM0178, ARWM0179, ARWM0180, ARWM0181, ARWM0184, ARWM0215, ARWM0216, ARWM0217, ARWM0219, ARWM0224, ARWM0232, ARWM0284, ARWM0285, ARWM0286, ARWM0287, ARWM0288, ARWM0289, ARWM0308, ARWM0309, ARWM0310, ARWM0311, ARWM0313, ARWM0314, ARWM0315, ARWM0323, ARWM0326, ARWM0327, ARWM0328, ARWM0329, ARWM0330, ARWM0331, ARWM0333, ARWM0335, ARWM0337, ARWN0001, ARWN0002, ARWN0003, ARWN0005, ARWN0014, ARWN0015, ARWN0016, ARWN0017, ARWN0018, ARWN0019, ARWN0022, ARWN0023, ARWN0024, ARWN0025, ARWN0026, ARWN0027, ARWN0028, ARWN0029, ARWN0030, ARWN0031, ARWN0033, ARWN0034, ARWN0035, ARWN0036, ARWN0037, ARWN0038, ARWN0039, ARWN0040, ARWN0041, ARWN0042, ARWN0043, ARWN0044, ARWN0045, ARWN0046, ARWN0058, ARWN0060, ARWN0061, ARWN0062, ARWN0063, ARWN0064, ARWN0065, ARWN0066, ARWN0067, ARWN0076, ARWN0078, ARWN0080, ARWN0081, ARWN0082, ARWN0083, ARWN0084, ARWN0085, ARWN0087, ARWN0088, ARWN0176, ARWN0184, and ARWN0214.
Recalling Firm/
Draeger Medical, Inc.
3135 Quarry Rd
Telford, Pennsylvania 18969-1042
For Additional Information Contact Technical Support
Manufacturer Reason
for Recall
Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.
FDA Determined
Cause 2
Action Consignees were notified by an Urgent Medical Device Recall letter sent on 2/7/08. The letter informed users that the recalling firm will contact them to schedule appointments to inspect any potentially affected machines. The letter instructed users to continue using the machines, before the inspection, making sure to carefully follow the warnings in the instruction manual. If a caster on the machine appears unstable before the inspection is conducted, users were advised to contact the recalling firm. For additional information, contact 1-800-543-5047.
Quantity in Commerce 196 UNITS
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DRAEGER MEDICAL, INC.