Draeger Medical, Inc.: Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969.

Recall number

Z-1315-2008

Recalling firm

Draeger Medical, Inc.

Product

Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969.

Status

Terminated

Initiated

2008-02-05

Posted

2008-07-16

Terminated

2008-09-09

Reason

Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.

Root cause

Nonconforming Material/Component

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

196 UNITS

Distribution

Nationwide Distribution.

Lot, serial or model codes

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.

510(k) numbers

["K042419"]

PMA numbers

not on file

Product code

BSZ

Firm FEI

2517967

Firm city

Telford

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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