FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Equator Forced Air Convective Warming System, Reference Number EQ 5000
- Recall number
- Z-0497-05
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Equator Forced Air Convective Warming System, Reference Number EQ 5000
- Status
- Terminated
- Initiated
- 2004-12-15
- Posted
- 2005-02-03
- Terminated
- 2006-06-27
- Reason
- Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt
- Root cause
- Other
- Action
- Smiths Medical ASD notified customers by letter issued Fed''X on 12/15/04. Accounts are requested not to use the device and return the unit if the the unit has not yet been placed into service. If the unit has been placed into service and operated for more than one hour then the problem will not occur. EQ-5000 unit(s) will be replaced.
- Quantity
- 206 units
- Distribution
- Nationwide Foreign: Nederland BV, UK, Finland
- Lot, serial or model codes
- Serial No. 2004126, 10040116, 20020088, 20020125, 20030104, 20030105, 20030133, 20030141, 20030146, 20030194, 20030199, 20030254, 20030287, 20030312, 20030394, 20030401, 20030408, 20030428, 20030460, 20030512, 20030522, 20030535, 20030627, 20030665, 20030759, 20030791, 20030818, 20030960, 20031030, 20031034, 20031039, 20031049, 20031056, 20031105, 20031151, 20031164, 20031172, 20031271, 20031336, 20031414, 20031417, 20031418, 20031423, 20031444, 20031488, 20031550, 20031622, 20031632, 20031661, 20031669, 20031681, 20040007, 20040010, 20040014, 20040021, 20040104, 20040106, 20040115, 20040124, 20040127, 20040153, 20040162, 20040164, 20040166, 20040202, 20040203, 20040208, 20040227, 20040290, 20040377, 20040378, 20040379, 20040380, 20040381, 20040382, 20040383, 20040385, 20040386, 20040387, 20040388, 20040389, 20040391, 20040392, 20040393, 20040394, 20040395, 20040396, 20040397, 20040398, 20040399, 20040400, 20040401, 20040402, 20040406, 20040408, 20040409, 20040410, 20040412, 20040414, 20040415, 20040416, 20040419, 20040420, 20040422, 20040427, 20040429, 20040505, 20040715, 20040817, 20040996, 20041156, 20041157, 20041158, 20041159, 20041160, 20041161, 20041162, 20041163, 20041164, 20041165, 20041166, 20041167, 20041168, 20041169, 20041170, 20041171, 20041172, 20041173, 20041174, 20041175, 20041176, 20041177, 20041178, 20041179, 20041180, 20041181, 20041182, 20041183, 20041184, 20041185, 20041186, 20041187, 20041188, 20041189, 20041190, 20041191, 20041192, 20041193, 20041194, 20041195, 20041196, 20041197, 20041198, 20041199, 20041200, 20041201, 20041202, 20041203, 20041204, 20041205, 20041206, 20041207, 20041208, 20041209, 20041210, 20041211, 20041212, 20041213, 20041214, 20041215, 20041216, 20041217, 20041218, 20041219, 20041220, 20041221, 20041222, 20041223, 20041224, 20041225, 20041227, 20041228, 20041229, 20041230, 20041231, 20041232, 20041233, 20041234, 20041235, 20041236, 20041237, 20041238, 20041239, 20041240, 20041241, 20041242, 20041244, 20041245, 20041246, 20041247, 20041249, 20041250, 20041251, 20041253, 20041256, 20041257, 20041258, 20041259, 20041260, 20041261, 20041262, 20041263, 20041264, 20041265, 20041266, 20041267, 20041268, 20041269, 20041270, 20041271, 20041272, 20041273, 20041274, 20041275, 20041276, 20041277, 20041278, 20041279, 20041280, 20041281, 20041282, 20041283, 20041284, 20041285, 20041286, 20041287, 20041288, 20041289, 20041290, 20041291, 20041293, 20041294, 20041295, 20041296, 20041297, 20041298, 20041299, 20041300, 20041301, 20041302, 20041303, 20041304, 20041305, 20041306, 20041307, 20041308, 20041309, 20041310, 20041311, 20041312, 20041313, 20041314, 20041315, 20041316, 20041317, 20041318, 20041319, 20041320, 20041321, 20041322, 20041323, 20041324, 20041325, 20041326, 20041327, 20041364, 20041581, 29941255
- 510(k) numbers
- K011907
- PMA numbers
- not on file
- Product code
- DWJ
- Firm FEI
- 1221261
- Firm city
- Rockland
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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