FDA Device Recall Z-0042-2015: Mckesson Information Solutions LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0042-2015.

Recall Res Number

Z-0042-2015

Recalling Firm / Manufacturer

Mckesson Information Solutions LLC

FEI Number

3002684279

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2014-08-27

Date Posted

2014-10-08

Date Terminated

2016-05-18

Product Code

MWI

Event Number

69377

Product Quantity

272 devices

Product Description McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.

Reason for Recall Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.

Action Details On August 27, 2014, McKesson initiated a correction via a Field Safety Notice to all affected domestic customers. McKesson Israel will be responsible for contacting foreign consignees.

Distribution Pattern Worldwide distribution: US (nationwide) including states of: AR, CA, FL, DE, GA, HI, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NJ, NV, OK, PA, SC, TNTX, , UT, WA; and countries of: Australia, Canada, Israel and the United Kingdom.

Code Information / Serial Numbers McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.

Related Establishments / Registrations

DRE Med Registration: 1000122786 View Registration
INVIVO CORPORATION Registration: 1051786 View Registration
TOYO MEDICAL CO. Registration: 1054713 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
DIGICARE BIOMEDICAL TECHNOLOGY, INC. Registration: 1062836 View Registration
POLYZEN, LLC Registration: 1064859 View Registration
ADVANCED INSTRUMENTATIONS, INC. Registration: 1066270 View Registration
INFINIUM MEDICAL, INC. Registration: 1066427 View Registration
ZOLL MEDICAL CORPORATION Registration: 1220908 View Registration
IVY BIOMEDICAL SYSTEMS, INC. Registration: 1221108 View Registration
GREGORY MFG., INC. Registration: 1222630 View Registration
WELCH ALLYN, INC. Registration: 1316463 View Registration
MIDMARK CORPORATION Registration: 1523530 View Registration
SCOTTCARE CORPORATION Registration: 1527715 View Registration
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES Registration: 1651104 View Registration
INSTRU-MED TECHNOLOGIES Registration: 1833920 View Registration
KATECHO LLC Registration: 1930027 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
HILL-ROM, INC. Registration: 2027454 View Registration
Nihon Kohden Digital Health Solutions, LLC. Registration: 2032233 View Registration
NIHON KOHDEN AMERICA, INC. Registration: 2080783 View Registration
NORTECH SYSTEMS, INC. Registration: 2183613 View Registration
MINDRAY DS USA, Inc. Registration: 2221819 View Registration
Bayer Medical Care Inc. Registration: 2520313 View Registration
Covidien Registration: 2936999 View Registration
SCIMAGE, INC. Registration: 2952596 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
ANALOG DEVICES Registration: 3000130829 View Registration
Philips Medical Systems Nederland B.V. Registration: 3000976525 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3001570235 View Registration
East West Wisconsin Registration: 3002736372 View Registration
NextPhase Medical Devices, LLC Registration: 3003174284 View Registration
ZOE MEDICAL, INC. Registration: 3003294644 View Registration
Flextronics Manufacturing (Singapore) Pte Ltd Registration: 3003589956 View Registration
MEDIANA CO., LTD. Registration: 3003591740 View Registration
Philips France Registration: 3003630387 View Registration
BIONET CO., LTD. Registration: 3003681187 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3003768277 View Registration
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. Registration: 3003832357 View Registration
EDAN INSTRUMENTS, INC. Registration: 3003971136 View Registration
GlobalMed Holdings, LLC Registration: 3004009431 View Registration
ActiGraph L.L.C. Registration: 3004091281 View Registration
TAIDOC TECHNOLOGY CORPORATION Registration: 3004145393 View Registration
B & G MFG. CO. Registration: 3004188066 View Registration
Industrial Vallera de Mexicali, S. A. de C. V. Registration: 3004415095 View Registration
InfuSystem Inc. Registration: 3004906872 View Registration
IRADIMED CORPORATION Registration: 3005053560 View Registration
ANYBATTERY, INC Registration: 3005521864 View Registration
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Registration: 3005569927 View Registration
THORNHILL RESEARCH INC. Registration: 3005803793 View Registration
AirStrip Technologies, Inc. Registration: 3006104191 View Registration
LD TECHNOLOGY LLC Registration: 3006146787 View Registration
Creative Foam Corporation dba MT. OLIVE MFG Registration: 3006240053 View Registration
FABRINET CO., LTD. Registration: 3006546174 View Registration
Sanmina-SCI Systems Singapore Pte. Ltd. Registration: 3006606827 View Registration
Philips North America LLC Registration: 3006648320 View Registration
SHENZHEN CREATIVE INDUSTRY CO., LTD Registration: 3006733253 View Registration
IEI Integration Corp. Registration: 3006808382 View Registration
CONTEC MEDICAL SYSTEMS CO., LTD Registration: 3006979678 View Registration
AMPHENOL ALDEN PRODUCTS COMPANY Registration: 3007029079 View Registration
FORA CARE INC. Registration: 3007134734 View Registration
Avnet Global Solution Center Registration: 3007137598 View Registration
GUANGDONG BIOLIGHT MEDITECH CO., LTD Registration: 3007305624 View Registration
ATHENA GTX Registration: 3007413079 View Registration
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center Registration: 3007481893 View Registration
Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration
INNOKAS MEDICAL OY Registration: 3007615597 View Registration
HOSMED INC. Registration: 3007836437 View Registration
WUHAN STRONG ELECTRONICS Registration: 3008164770 View Registration
Kimball Solutions Jasper, Inc. Registration: 3008253300 View Registration
HI-TECH PRODUCTS DE MEXICO S.A. DE C.V. Registration: 3008255748 View Registration
TONTEC PRECISION PLASTICS TECHNOLOGY (SHENZHEN) CO. LTD. Registration: 3008283443 View Registration
ARMORLINK SH CORP Registration: 3008365372 View Registration
SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD. Registration: 3008716327 View Registration
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. Registration: 3008729547 View Registration
Norav Medical Inc. Registration: 3008977358 View Registration
SKANRAY TECHNOLOGIES LIMITED Registration: 3009001657 View Registration
DHL SUPPLY CHAIN (NETHERLANDS) B.V. Registration: 3009077524 View Registration
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3009156722 View Registration
Proactive Medical Products Registration: 3009327812 View Registration
EDAN Diagnostics, Inc. Registration: 3009499478 View Registration
HCLTech Registration: 3009503584 View Registration
SOTERA WIRELESS Registration: 3009673645 View Registration
MASIMO CORPORATION Registration: 3009831876 View Registration
Ferry Machine Corporation Registration: 3009959868 View Registration
FIRST ARTICLE INC Registration: 3010032903 View Registration
J&B PRECISION, INC. Registration: 3010041430 View Registration
Millstone Medical Outsourcing LLC Registration: 3010097171 View Registration
FLEX-CELL PRECISION, INC. Registration: 3010120135 View Registration
J & J Precision Technologies, LLC Registration: 3010120148 View Registration
Spacelabs Healthcare Inc. Registration: 3010157426 View Registration
TRIBALCO Registration: 3010317211 View Registration
MEDISONO, LLC Registration: 3010390468 View Registration
Medical Informatics Corp. Registration: 3010392999 View Registration
Innokas Medical Estonia Ou Registration: 3010399798 View Registration
SIGNA MEDICAL, INC. Registration: 3010419931 View Registration
Ambient Clinical Analytics Registration: 3010692333 View Registration
FYSICON BV Registration: 3010716438 View Registration
FABRITEQ Registration: 3010824458 View Registration
AXIAL MEDICAL Registration: 3010863450 View Registration
SHENZHEN VIATOM TECHNOLOGY CO., LTD. Registration: 3011200896 View Registration
MASIMO CORPORATION Registration: 3011353843 View Registration
DICTUM HEALTH, INC. Registration: 3011359729 View Registration
Eko Health, Inc. Registration: 3011651230 View Registration
ETIOMETRY INC. Registration: 3011683100 View Registration
TALIS CLINICAL LLC Registration: 3012103976 View Registration
CRITICARE TECHNOLOGIES, INC. Registration: 3012238587 View Registration
Flash Global Registration: 3012251275 View Registration
GE Medical Systems Information Technologies, Inc. Registration: 3012359877 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
SANICURE BV Registration: 3012494290 View Registration
Philips North America LLC Registration: 3012528160 View Registration
EMPATICA S.r.l. Registration: 3012933969 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration
Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Registration: 3013500228 View Registration
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center Registration: 3013501110 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
Amphenol Medical Technologies (Dongguan) Co., Ltd. Registration: 3013596024 View Registration
Hypertec HCM LLC Registration: 3013896610 View Registration
Philips Clinical Informatics Registration: 3014128039 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC. Registration: 3014856521 View Registration
INTOPS CO.,LTD. Registration: 3014886121 View Registration
Tianjin Choice Medical Device Co., Ltd. Registration: 3015142815 View Registration
SIBEL HEALTH INC. Registration: 3015529350 View Registration
Philips North America LLC Registration: 3016618143 View Registration
HUMA THERAPEUTICS LIMITED Registration: 3016670256 View Registration
Industrial Vallera de Mexicali, S.A. de C.V. (Terra) Registration: 3016674095 View Registration
Philips North America LLC Registration: 3016701404 View Registration
Nihon Kohden Corporation - Eastern Japan Logistics Center Registration: 3016852448 View Registration
JPEX MEDICAL EQUIPMENT & SUPPLIES, INC. Registration: 3016931915 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
LUXSHARE - ICT (NGHE AN ) LIMITED Registration: 3018514222 View Registration
Masimo Corporation Registration: 3019388613 View Registration
TONTEC INTERNATIONAL LTD. Registration: 3019834104 View Registration
LINAMAR INNOVATION HUB Registration: 3020476987 View Registration
NIMBLEHEART, INC. Registration: 3021219789 View Registration
OSI SYSTEMS PVT LTD(OPTOELECTRONICS DIVISION) Registration: 3021343210 View Registration
IVUS ILAC SANAYI VE TICARET AS Registration: 3021632375 View Registration
IEI INTEGRATION CORP. Registration: 3022425463 View Registration
AIDAR HEALTH, INC Registration: 3023412068 View Registration
MEDWAND SOLUTIONS, INC Registration: 3024491912 View Registration
Masimo Medical Technologies (Malaysia) SDN BHD Registration: 3027256461 View Registration
ZOLL International Holding B.V. Registration: 3029871637 View Registration
PHARMCO MEDICAL BV Registration: 3030447506 View Registration
Laerdal Medical AS, Stavanger Manufacturing Registration: 3031563234 View Registration
BEIJING CHOICEMMED TECHNOLOGY CO., LTD. Registration: 3032013079 View Registration
HAPPY HEALTH Registration: 3033715634 View Registration
Jaeger Medical America Inc. Registration: 3033959233 View Registration
ORDINATRUM HEALTH Registration: 3034603598 View Registration
GAMAMED VASCULAR SYSTEMS INC. Registration: 3035111606 View Registration
WARD 24/7 Registration: 3036798186 View Registration
LONGCHEER MEIKO ELECTRONICS VIETNAM COMPANY LIMITED Registration: 3037341611 View Registration
ZOLL MEDICAL CORPORATION Registration: 3038259592 View Registration
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Registration: 3042175844 View Registration
FERRY MACHINE CORPORATION Registration: 3043543260 View Registration
MIDMARK CORP. Registration: 3043668257 View Registration
RUDOLF RIESTER GMBH Registration: 8010482 View Registration
LEONHARD LANG GMBH Registration: 8020045 View Registration
COSMED S.R.L. Registration: 8021084 View Registration
CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration
NIHON KOHDEN TOMIOKA PRODUCTION CENTER Registration: 8030229 View Registration
Syrma Johari MedTech Limited Registration: 8040537 View Registration
VTech Communications Ltd Registration: 8040564 View Registration
MIPM Mammendorfer Institut fur Physik und Medizin GmbH Registration: 8043459 View Registration
GE HEALTHCARE FINLAND OY Registration: 9610105 View Registration
Philips Medizin Systeme Boeblingen GmbH Registration: 9610816 View Registration
NIHON KOHDEN CORP. Registration: 9611252 View Registration
SCHILLER MEDICAL Registration: 9611348 View Registration
Draegerwerk AG & Co. KGaA Registration: 9611500 View Registration
Jaeger Medical GmbH Registration: 9615102 View Registration
Change Healthcare Israel Ltd. Registration: 9616760 View Registration
VELCROMEX, S.A. DE C.V. Registration: 9680215 View Registration
NORAV MEDICAL LTD. Registration: 9681548 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0042-2015

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer