FDA Device Recall Z-0037-06: Datex-Ohmeda Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0037-06.

Recall Res Number

Z-0037-06

Recalling Firm / Manufacturer

Datex-Ohmeda Inc

FEI Number

2183066

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-09-27

Date Posted

2005-10-12

Date Terminated

2007-04-01

Product Code

BSZ

Event Number

33678

Product Quantity

367

Product Description Datex-Ohmeda S/5 Aespire Anesthesia System 7100

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.

Action Details Urgent 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.

Distribution Pattern CA, 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.

Code Information / Serial Numbers 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

Related Establishments / Registrations

DRE Med Registration: 1000122786 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
ADVANCED INSTRUMENTATIONS, INC. Registration: 1066270 View Registration
INFINIUM MEDICAL, INC. Registration: 1066427 View Registration
CODONICS, INC. Registration: 1530958 View Registration
ACCUTRON, INC. Registration: 2020813 View Registration
Datex-Ohmeda, Inc. Registration: 2112667 View Registration
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Registration: 2183066 View Registration
MINDRAY DS USA, Inc. Registration: 2221819 View Registration
PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP. Registration: 2518157 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
DRAEGERWERK AG & CO. KGAA Registration: 3001104093 View Registration
Flextronics Manufacturing (Singapore) Pte Ltd Registration: 3003589956 View Registration
DRAEGER MEDICAL SYSTEMS, INC. Registration: 3005783425 View Registration
THORNHILL RESEARCH INC. Registration: 3005803793 View Registration
BEIJING AEONMED CO., LTD. Registration: 3007238566 View Registration
Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration
Oricare Inc. Registration: 3009129579 View Registration
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3009156722 View Registration
Spacelabs Healthcare Inc. Registration: 3010157426 View Registration
MAKAR CONSULTING PTY LTD Registration: 3010703925 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
Philips North America LLC Registration: 3016618143 View Registration
CAF MEDICAL SOLUTIONS INC Registration: 3021559257 View Registration
SHENZHEN PRUNUS MEDICAL CO.,LTD. Registration: 3022543477 View Registration
GAMAMED VASCULAR SYSTEMS INC. Registration: 3035111606 View Registration
MAQUET CRITICAL CARE AB Registration: 8010042 View Registration
GALEMED CORP. Registration: 8043316 View Registration
PENLON LTD. Registration: 9610531 View Registration
SPACELABS HEALTHCARE LTD. Registration: 9611295 View Registration
Draegerwerk AG & Co. KGaA Registration: 9611500 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9617604 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration

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Medical Device Recall: Z-0037-06

Recall Parameters & Description

Related Establishments / Registrations

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