FDA Device Recall Z-0003-2010: Philips Healthcare Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0003-2010.

Recall Res Number

Z-0003-2010

Recalling Firm / Manufacturer

Philips Healthcare Inc.

FEI Number

1218950

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2009-08-21

Date Posted

2009-11-09

Date Terminated

2017-04-25

Product Code

MKJ

Event Number

52990

Product Quantity

1,523 units

Product Description HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

Reason for Recall incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC or DC power

Action Details Philips Healthcare issued a Urgent Voluntary Medical Device Correction Notification on August 21, 2009 advising users of the problem and Customers are asked to follow the "Action to be taken by customer/user" section of the Urgent Voluntary Medical Device Correction Notification. In this section, customers are given the instructions to correct their devices. For further information or support concerning this issue, please contact Philips representative at 1-800-722-9377.

Distribution Pattern Nationwide Canada Australia, Austria, Beharin, BRUNEI DARUSSALAM,Chian,. Finland, France, Germany,Hong Kong, India, Indonesia, Ireland, Israel,Italy, Japan, Libya, Lithuania. Mexico, Nambia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, UAE, UK

Code Information / Serial Numbers Serial numbers within the following range. US00533518 through US00535118.

Related Establishments / Registrations

ZOLL Medical Corporation Registration: 1218058 View Registration
Philips North America LLC Registration: 1218950 View Registration
Cardinal Health Registration: 1219103 View Registration
ZOLL MEDICAL CORPORATION Registration: 1220908 View Registration
Conmed Corporation Registration: 1223925 View Registration
Graphic Controls Acquisition Corp.dba Nissha Medical Technologies Registration: 1317188 View Registration
CONMED CORPORATION Registration: 1320894 View Registration
Cardinal Health 200, LLC Registration: 1423537 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1720929 View Registration
Cardinal Health Registration: 1921846 View Registration
KATECHO LLC Registration: 1930027 View Registration
ZOLL Medical Corporation Registration: 2112020 View Registration
R & D BATTERIES, INC. Registration: 2132111 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
ITECH Registration: 3002714378 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
DEFIBTECH, LLC Registration: 3003521780 View Registration
TECAN CDMO SOLUTIONS MH, CORP. Registration: 3003537036 View Registration
CADEX ELECTRONICS, INC. Registration: 3003800159 View Registration
ANSEN CORPORATION Registration: 3003867964 View Registration
BERND RICHTER GMBH Registration: 3004035727 View Registration
HEARTSINE TECHNOLOGIES, LTD Registration: 3004123209 View Registration
InfuSystem Inc. Registration: 3004906872 View Registration
KEMP LLC Registration: 3005621729 View Registration
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. Registration: 3005906887 View Registration
AEROSPACE ACCESSORY SERVICES INC Registration: 3006108746 View Registration
AMPHENOL ALDEN PRODUCTS COMPANY Registration: 3007029079 View Registration
QUIPMENT Registration: 3008717264 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
AED Battery Exchange, LLC Registration: 3009886119 View Registration
PHYSIO-CONTROL MAASTRICHT, INC. Registration: 3010030355 View Registration
TRIBALCO Registration: 3010317211 View Registration
MAKAR CONSULTING PTY LTD Registration: 3010703925 View Registration
EMS SURPLUS CANADA Registration: 3010839093 View Registration
Greatbatch Medical S. de R.L. de C.V. Registration: 3011823740 View Registration
Katmai Health Services LLC Registration: 3012104670 View Registration
SANICURE BV Registration: 3012494290 View Registration
HI MEDICAL CO., LTD. Registration: 3012502601 View Registration
Philips North America LLC Registration: 3012607778 View Registration
Defibtech Branford Registration: 3012972516 View Registration
Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Registration: 3013500228 View Registration
KM Medical Registration: 3013517171 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
Amphenol Medical Technologies (Dongguan) Co., Ltd. Registration: 3013596024 View Registration
RRC POWER SOLUTIONS LTD. Registration: 3013826848 View Registration
C MEDICAL SUPPLIES Registration: 3014572985 View Registration
TECAN CDMO SOLUTIONS PN SDN. BHD. Registration: 3015134086 View Registration
PHYSIO-CONTROL, INC. Registration: 3015876 View Registration
KATMAI INTEGRATED SOLUTIONS Registration: 3015997711 View Registration
EMI (DONGGUAN) ASIA LIMITED Registration: 3017422354 View Registration
BOUND TREE MEDICAL, LLC Registration: 3020460367 View Registration
CAF MEDICAL SOLUTIONS INC Registration: 3021559257 View Registration
AVIVE SOLUTIONS INC Registration: 3026007685 View Registration
DEFIBTECH LLC Registration: 3026976873 View Registration
TZ MEDICAL, INC. Registration: 3027815 View Registration
ZOLL International Holding B.V. Registration: 3029871637 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
Philips North America LLC Registration: 3030677 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
ZOLL MEDICAL CORPORATION Registration: 3038259592 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
LEONHARD LANG GMBH Registration: 8020045 View Registration
NEW DEANTRONICS TAIWAN LTD. Registration: 9681191 View Registration
Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) Registration: 9681860 View Registration

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Medical Device Recall: Z-0003-2010

Recall Parameters & Description

Related Establishments / Registrations

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