FDA Device Recall Z-0036-06: Recall Record

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0036-06.

Recall Res Number

Z-0036-06

Recalling Firm / Manufacturer

N/A

FEI Number

1220672

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-09-13

Date Posted

2005-10-12

Date Terminated

2006-08-07

Product Code

HGM

Event Number

33337

Product Quantity

13 units

Product Description FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)

Reason for Recall Unit may not power up due to faulty circuit board

Action Details Analogic notified customers by letter dated 9/13/05. Distributors were requested to notify their accounts and return units for replacement of the main circuit board.

Distribution Pattern CT, PR Foreign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia

Code Information / Serial Numbers Serial Numbers: FA002010 FA002051 FA002054 FA002059 FA002061 FA002062 FA002064 FA002011 FA002013 FA002014 FA002056 FA002065 FA002058

Related Establishments / Registrations

DRE Med Registration: 1000122786 View Registration
LEBANESE INTERNATIONAL TECHNOLOGIES Registration: 1000576299 View Registration
HUNTLEIGH HEALTHCARE LTD. Registration: 1000589001 View Registration
ADVANCED INSTRUMENTATIONS, INC. Registration: 1066270 View Registration
AMERICAN I.V. PRODUCTS, INC. Registration: 1121996 View Registration
Philips North America LLC Registration: 1218950 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
MEDGYN PRODUCTS, INC. Registration: 1450908 View Registration
KATECHO LLC Registration: 1930027 View Registration
CLINICOMP INTL., INC. Registration: 2028916 View Registration
R & D BATTERIES, INC. Registration: 2132111 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3001570235 View Registration
BIONET CO., LTD. Registration: 3003681187 View Registration
EDAN INSTRUMENTS, INC. Registration: 3003971136 View Registration
CETRO AMERICA Registration: 3004167720 View Registration
CLINICAL COMPUTER SYSTEMS, INC. Registration: 3004423584 View Registration
GE HEALTHCARE Registration: 3004526608 View Registration
LUEN HING TEXTILE -Shangyu Manufacturing(ZHONG SHAN) CO LTD Registration: 3004566918 View Registration
AirStrip Technologies, Inc. Registration: 3006104191 View Registration
Bistos co., ltd. Registration: 3006179052 View Registration
CHINA QINGDAO BRIGHT MEDICAL MANUFACTURING CO.,LTD. Registration: 3007048259 View Registration
AccuMed Corp. Registration: 3007309299 View Registration
TIOGA LIMITED Registration: 3007607999 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
TENACORE LLC Registration: 3008403701 View Registration
QUIPMENT Registration: 3008717264 View Registration
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. Registration: 3008729547 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
EDAN Diagnostics, Inc. Registration: 3009499478 View Registration
MEDISONO, LLC Registration: 3010390468 View Registration
B'ORZE INC Registration: 3010395077 View Registration
Natus Neurology Incorporated Registration: 3010611950 View Registration
GWW Registration: 3010698831 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3012359877 View Registration
Philips North America LLC Registration: 3012528160 View Registration
WATCHCHILD, LLC Registration: 3013400897 View Registration
Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Registration: 3013500228 View Registration
Cerner Corporation Registration: 3013546957 View Registration
Amphenol Medical Technologies (Dongguan) Co., Ltd. Registration: 3013596024 View Registration
ORANTECH INC. Registration: 3013783488 View Registration
Datex-Ohmeda, Inc. Registration: 3014220748 View Registration
Philips Medical Systems Ltda Registration: 3014541700 View Registration
SIBEL HEALTH INC. Registration: 3015529350 View Registration
Philips North America LLC Registration: 3016618143 View Registration
Philips North America LLC Registration: 3016701404 View Registration
HUBDIC USA INC Registration: 3021635975 View Registration
Datex-Ohmeda, Inc. Registration: 3036470679 View Registration
GE HEALTHCARE FINLAND OY Registration: 9610105 View Registration
Philips Medizin Systeme Boeblingen GmbH Registration: 9610816 View Registration
PeriGen Solutions Ltd. Registration: 9615396 View Registration
Wipro GE Healthcare Private Ltd. Registration: 9617277 View Registration
VELCROMEX, S.A. DE C.V. Registration: 9680215 View Registration
Nicolay GMBH Registration: 9681377 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration

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Medical Device Recall: Z-0036-06

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer