Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66025

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 14, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Draeger Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.

Z-0008-2014
Recall number
Z-0008-2014
Initiated
August 14, 2013
Classification
Class I
Status
Terminated
Recalling firm
Draeger Medical, Inc.
Quantity
1127 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.

Code information

Part Nos. 8607000 (GS Permium) 8606000 (Fabius OS and Fabius Tiro) 8608400 (Fabius Tiro D-M)ASEC-0055 with lot numbers: ASEC-0186, ASED-0006, ASED-0074, ASED-0291, ASEC-0056, ASEC-0205, ASED-0007, SED-0075 ASED-0292, ASEC-0061, ASEC-0206, ASED-0020, ASED-0079, ASED-0293, ASEC-0062, ASEC-0207, ASED-0021, ASED-0139, ASED-0294, ASEC-0070, ASEC-0208, ASED-0023, ASED-0160, ASED-0295, ASEC-0071, ASEC-0209, ASED-0024, ASED-0161, ASED-0296, ASEC-0112, ASEC-0210, ASED-0025, ASED-0162, ASEE-0021, ASEC-0124, SEC-0211, ASED-0031, ASED-0163, ASEE-0022, ASEC-0125, ASEC-0212, ASED-0032, ASED-0164, ASEE-0023, ASEC-0126, ASEC-0213, ASED-0033, ASED-0165, ASEE-0041, ASEC-0169, ASEC-0214, ASED-0034, ASED-0166, ASEE-0042, ASEC-0170, ASEC-0236, ASED-0035, ASED-0167, ASEE-0058, ASEC-0171, ASEC-0248, ASED-0036, ASED-0168, ASEE-0060, ASEC-0172, ASEC-0249, ASED-0037, ASED-0169, ASEE-0061, ASEC-0173, ASEC-0250, ASED-0038, ASED-0203, ASEE-0065, ASEC-0174, ASED-0001, ASED-0044, ASED-0253, ASEE-0066, ASEC-0175, ASED-0002, ASED-0045, ASED-0286, ASEE-0083, ASEC-0176, ASED-0003, ASED-0046, ASED-0287, ASEE-0103, ASEC-0184, ASED-0004, ASED-0047, ASED-0288, ASEE-0136, ASEC-0185, ASED-0005, ASED-0051, ASED-0290, ASEC-0054, ASEC-0194, ASED-0247, ASED-0263, ASEE-0072, ASEC-0167, ASEC-0195, ASED-0248, ASED-0264, ASEE-0089, ASEC-0178, ASEC-0196, ASED-0254, ASED-0265, ASEE-0090, ASEC-0179, ASEC-0197, ASED-0255, ASED-0266, ASEE-0131, ASEC-0180, ASEC-0227, ASED-0256, ASED-0282, ASEE-0132, ASEC-0181, ASEC-0228, ASED-0257, ASEE-0003, ASEE-0133, ASEC-0182, ASED-0040, ASED-0260, ASEE-0017, ASEE-0134, ASEC-0183, ASED-0086, ASED-0261, ASEE-0054, ASEC-0193, ASED-0245, ASED-0262, ASEE-0071, ASED-0141, ASED-0143, ASED-0145, ASED-0147, ASED-0149, ASED-0142, ASED-0144, ASED-0146, ASED-0148, ASEB-0219

Distribution pattern

Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Libya, Lithuania Malaysia, Morocco, Myanmar, Nepal, Philippines, Poland, Rumania, Russian Fed., Saudi Arabia, Senegal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Uruguay, Vietnam, White Russia Turkmenistan.