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FDA Medical Device Recalls (openFDA)

Datex-Ohmeda Inc: Datex-Ohmeda S/5 Anesthesia Delivery Units

Recall number
Z-0937-03
Recalling firm
Datex-Ohmeda Inc
Product
Datex-Ohmeda S/5 Anesthesia Delivery Units
Status
Terminated
Initiated
2003-07-15
Posted
2003-08-28
Terminated
2005-11-08
Reason
Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
Root cause
Other
Action
Recall letters dated July 15, 2003 stated that a firm representative would contact the consignees to schedule a visit to replace CPU boards to correct the problem.
Quantity
544 units
Distribution
The product was distributed nationwide to hospitals in the Unites States.
Lot, serial or model codes
Serial numbers: 40022312, 40022313, 40027688, 40032184, 40032233, 4002321, 40032330, 40032546, 40036365, 40043483, 40043493 through 40043495, 40043497, 40054495, 40065046, 40065073, 40065818, 40067311, 40067345, 40080026, 40080031, 40080032, 40080035 through 40080037, 40080039, 40080041, 40080042, 40080056, 40080063, 40080064, 40080070, 40080073, 40082935, 40082937 through 40082941, 40082975, 40082979, 40082980, 40082981, 40082986 through 40082989, 40083005, 40083008 through 40083028, 40084505, 40084508, 40084509, 40084512, 40084523, 40084524, 40084535 through 40084538, 40085637, 40085638, 40085642 through 40085644, 40085656, 40085666, 40085681, 40085683 through 40085698, 40085700, 40085702 through 40085707, 40085710 through 40085712, 40085723, 40085734 through 40085736, 40086464, 40088538, 40088544 through 40088548, 40088550 through 40088553, 40088574, 40088585, 40088586, 40089324 through 40089328, 40089333 through 40089340, 40089342 through 40089350, 40089359 through 40089363, 40089398, 40089402, 40089420, 40089421, 40092286, 40092287, 40092290, 40092291, 40092368 through 40092372, 40094139, 40094140, 40094142 through 40094149, 40095400 through 40095433, 40097292 through 40097298, 40097314 through 40097319, 40097321, 40098708, 40098711, 40098714, 40098716 through 40098719, 40098725 through 40098738, 40098751 through 40098754, 40100505 through 40100510, 40102542, 40102543, 40103791, 40103792, 40103796, 40103809, 40103810, 40103817, 40103820, 40103821, 40104726, 40104728, 40104733 through 40104747, 40105932, 40105933, 40105944 through 40105946, 40105952 through 40105954, 40106542 through 40106547, 40106549, 40106551, 40106552, 40106568 through 40106585, 40107959, 40107963, 40107964, 40107976 through 40107985, 40107990 through 40107996, 40107998, 40108817, 40108821, 40108832 through 40108846, 40108848 through 40108850, 40108853, 40109523 through 40109525, 40109531, 40109532, 40109534 through 40109544, 40109546, 40109550, 40110654 through 40110673, 40110684 through 40110688, 40110700, 40110702, 40110703, 40111775 through 40111783, 40111791 through 40111795, 40111804, 40111807 through 40111809, 40112657, 40112659 through 40112661, 40113737, 40113747 through 40113749, 40113755, 40113761, 40113762, 40113767, 40113768, 40113770 through 40113774, 40114922 through 40114928, 40114931 through 40114933, 40115990 through 40116023, 40117237 through 40117244, 40118114 through 40118116, 40118125, 40119844, 40119864, 40119867 through 40119873, 40120169 through 40120178, 40120182, 40120183, 40120908 through 40120917, 40120920, 40120924, 40120929, 40120930, 40120932, 40122181, 40122187, 40122189, 40122627, and 40132124
510(k) numbers
["K973985"]
PMA numbers
not on file
Product code
BSZ
Firm FEI
2183066
Firm city
Madison
Firm state
WI
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

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