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U.S. Department of Health and Human Services

Class 2 Device Recall DatexOhmeda S/5 Aespire Anesthesia System 7100

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 Class 2 Device Recall DatexOhmeda S/5 Aespire Anesthesia System 7100see related information
Date Initiated by FirmSeptember 27, 2005
Date PostedOctober 12, 2005
Recall Status1 Terminated 3 on April 01, 2007
Recall NumberZ-0037-06
Recall Event ID 33678
510(K)NumberK000706 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
ProductDatex-Ohmeda S/5 Aespire Anesthesia System 7100
Code Information AMXJ00203, AMXJ00204, AMXJ00248 thru AMXJ00257, AMXJ00259, AMXJ00260, AMXJ00262 thru AMXJ00305, AMXJ00308 thru AMXJ00312, AMXJ00317, AMXJ00318, AMXJ00333 thru AMXJ00335, AMXJ00338 thru AMXJ00342, AMXJ00350 thru AMXJ00354, AMXJ00380 thru AMXJ00411, AMXJ00416, AMXJ00419 thru AMXJ00425, AMXJ00429 thru AMXJ00442, AMXJ00451 thru AMXJ00473, AMXJ00485 thru AMXJ00576, ZMXJ00581 thru AMXJ00629, AMXJ00631 thru AMXJ00639, AMXJ00641 thru AMXJ00699
Recalling Firm/
Manufacturer		 Datex-Ohmeda Inc
3030 Ohmeda Drive
PO Box 7550, zip 53707-7550
Madison WI 53718
Manufacturer Reason
for Recall		Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. Also the O2 switch may leak or fail.
FDA Determined
Cause 2		Other
ActionUrgent Medical Device Correction letter dated 09/23/05 was sent to all customers. The letter describes the issues, affected device serial numbers and recommends that customers DO NOT USE the internal auxiliary oxygen flowmeter, if installed in their system, and to use alternate auxiliary oxygen sources, i.e. wall-mounted oxygen flow meter, in the interim. A GE service representative will contact the customers to schedule an upgrade, performed at no charge.
Quantity in Commerce367
DistributionCA, CO, FL, GA, IL, IN, MI, MS, NM, OK, PA, PR, SD, UT & WA. OUS to: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Canada, Caribbean, Czech Republic, Chile, China, Colombia, Dominican Republic, Ecuador, Finland, France, Germany, Ghana, Great Britain, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Oman, Palestine, Peru, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Arab Emerites, Venezuela & Vietnam.
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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