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U.S. Department of Health and Human Services

Class 2 Device Recall DatexOhmeda

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 Class 2 Device Recall DatexOhmedasee related information
Date Initiated by FirmJuly 15, 2003
Date PostedAugust 28, 2003
Recall Status1 Terminated 3 on November 08, 2005
Recall NumberZ-0937-03
Recall Event ID 26765
510(K)NumberK973985 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
ProductDatex-Ohmeda S/5 Anesthesia Delivery Units
Code Information 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   
FEI Number 2183066
Recalling Firm/
Manufacturer		 Datex-Ohmeda Inc
One Ohmeda Dr. Box 7550
Madison WI 53707
For Additional Information ContactWilliam Exner
800-345-2700 Ext. 3115
Manufacturer Reason
for Recall		Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
FDA Determined
Cause 2		Other
ActionRecall 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 in Commerce544 units
DistributionThe product was distributed nationwide to hospitals in the Unites States.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BSZ
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