FDA Device Recall Z-0025-2018: Medtronic Navigation, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0025-2018.

Recall Res Number

Z-0025-2018

Recalling Firm / Manufacturer

Medtronic Navigation, Inc.

FEI Number

1000517638

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-07-27

Date Posted

N/A

Date Terminated

2019-08-05

Product Code

GEX

Event Number

77977

Product Quantity

423 devices

Product Description VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip

Reason for Recall The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.

Action Details All US consignees will be a sent a customer letter, dated July 27, 2017, via FedEx or Email. In addition, customers will be asked to return a signed consignee response form.

Distribution Pattern US nationwide distribution.

Code Information / Serial Numbers Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip Lots - 000212782059, 000212823919, 000212894256, 000212978141, 000212783784, 000212854585, 000212926008, 000212996201, 000212823883, 000212882619, 000212956163, 000213145362; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip Lots - 000212354781, 000212656015, 000212760821, 000212913269, 000212384009, 000212660280, 000212827856, 000212922387, 000212465594, 000212664497, 000212838837, 000212935278, 000212507737, 000212698642, 000212846727, 000213000097, 000212510629, 000212715926, 000212856596, 000213001255, 000212624409, 000212745633, 000212873863, 000213009483, 000212626439, 000212753561, 000212873873, 000213041517, 000212632885, 000212756095, 000212879480, 000213056030; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip Lots - 000212141557, 000212503634, 000212647830, 000212796559, 000212148368, 000212504463, 000212701679, 000212846726, 000212434500, 000212549456, 000212707035, 000212901580, 000212438405, 000212553428, 000212745660, 000212912501, 000212473141, 000212632884, 000212795235, 000212963182

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SHANGHAI BELE MEDICAL TECHNOLOGY CO.,LTD Registration: 3027619554 View Registration
B*G*MAKEOVERS ADVANCED SKIN CARE AND SPA Registration: 3027725665 View Registration
SANHE MEDITECH CO., LTD Registration: 3027851853 View Registration
The Beauty Tech Group LLC Registration: 3029083714 View Registration
MEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDA Registration: 3029897009 View Registration
MEDENCY SRL Registration: 3030090167 View Registration
K.P. IMPULSE GROUP INTERNATIONAL LTD. Registration: 3030125922 View Registration
RIVIC, LLC Registration: 3030230686 View Registration
CYDEN MEDICAL TECHNOLOGY (ZHEJIANG) CO., LTD Registration: 3030233762 View Registration
PRECISION IMPACTS LLC Registration: 3030418454 View Registration
XOD Inc Registration: 3030420005 View Registration
TROKA CANADA INC. Registration: 3030495752 View Registration
HEBEI NEWANGIE TECHNOLOGY CO., LTD Registration: 3030543531 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
FABINJECT LLC Registration: 3030979014 View Registration
LUNA AESTHETIC GROUP SL Registration: 3030979156 View Registration
SANHE JUMEI TECHNOLOGY CO.,LTD Registration: 3031233197 View Registration
HEBEI LUFEN TECH CO., LIMITED Registration: 3031233199 View Registration
BAODING TE'ANZHOU ELECTRONIC TECHNOLOGY CO.,LTD. Registration: 3031582430 View Registration
ROHRER AESTHETICS, INC. Registration: 3031944951 View Registration
HEBEI ZHEMAI TECHNOLOGY CO.,LTD Registration: 3032147807 View Registration
Enamel Pure Inc. Registration: 3032916575 View Registration
DAWELL MEDICAL, LLC Registration: 3033126947 View Registration
LIFE PRP Registration: 3033273466 View Registration
CURE POINT THERAPEUTICS, INC Registration: 3033274371 View Registration
SMEDTRUM MEDICAL TECHNOLOGY CO. LTD. Registration: 3033482500 View Registration
Cynosure Lutronic Technology Corporation Registration: 3033511105 View Registration
SRMC CO., LTD. Registration: 3033524191 View Registration
JEISYS MEDICAL NORTH AMERICA INC Registration: 3033715699 View Registration
REJUVA FRESH LLC Registration: 3033844600 View Registration
BEIJING MINGQIAO TECHNOLOGY CO. , LTD. Registration: 3033884002 View Registration
Guangzhou Enzoeys photoelectric Technology Co., Ltd. Registration: 3033891767 View Registration
BEIJING MEGA BEAUTY TECHNOLOGY CO.,LTD. Registration: 3033905238 View Registration
IDS LTD Registration: 3034246188 View Registration
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Registration: 3034630389 View Registration
VELABODY LLC Registration: 3034995492 View Registration
GENERAL AESTHETIC MANUFACTURING Registration: 3035375056 View Registration
TRIA LASER INC Registration: 3036240802 View Registration
BOSTON AESTHETICS INC Registration: 3036425107 View Registration
HEBEI KEYLASER SCI-TECH CO., LTD. Registration: 3037047060 View Registration
SOLAS MEDICAL LLC Registration: 3037874486 View Registration
Infinity Medical International LLC Registration: 3037966040 View Registration
MEDART TECHNOLOGY EUROPE Registration: 3038189188 View Registration
XEMIS MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD. Registration: 3038197172 View Registration
CARL ZEISS MEDITEC AG (JENA) Registration: 3038356864 View Registration
ELIXIR MD INC Registration: 3038372243 View Registration
LUNA X INC Registration: 3038373471 View Registration
REVIVE REGENERATIVE INC. Registration: 3038715747 View Registration
D.E.A. PROJECT S.R.L. Registration: 3039396569 View Registration
FOSHAN ZIKE TECHNOLOGY CO., LTD. Registration: 3040278125 View Registration
FABRINET CO., LTD. Registration: 3040278150 View Registration
NSON CO., LTD. Registration: 3041275224 View Registration
OMAN MEDICAL BEAUTY MANUFACTURE LIMITED Registration: 3042228064 View Registration
BEIJING SUNRISE SCIENCE TECHNOLOGY LIMITED Registration: 3042255006 View Registration
MICRO-ENERGY MEDICAL TECHNOLOGY CO., LTD. Registration: 3042261306 View Registration
menovex Medical Technology (Shenzhen) Co., Ltd Registration: 3042262496 View Registration
AXICON TECHNOLOGIES LLC Registration: 3042641021 View Registration
C3 SELECT LLC Registration: 3042953831 View Registration
HEBEI MITA BIOTECHNOLOGY LIMITED Registration: 3043011436 View Registration
GORGEOUS BEAUTY EQUIPMENT MANUFACTURE LIMITED Registration: 3043012074 View Registration
HEBEI MITA TECHNOLOGY LIMITED Registration: 3043012240 View Registration
BLINK BRIGHT MEDICAL, INC. Registration: 3043047259 View Registration
DEZHOU GLOBALIPL MEDICAL TECHNOLOGY CO., LTD. Registration: 3043127589 View Registration
GUANGDONG FUQIANG BEAUTY EQUIPMENT CO.,LIMITED Registration: 3043140693 View Registration
HEBEI TUOSITE TECHNOLOGY CO.,LTD Registration: 3043149902 View Registration
GUANGZHOU KONMISON TECHNOLOGY CO., LTD. Registration: 3043153468 View Registration
CHANGSHA GOMECY ELECTRONICS CO., LTD. Registration: 3043654467 View Registration
BEIJING BEAUTEMAX TECHNOLOGY LIMITED Registration: 3043657394 View Registration
Foshan Haiseer Electronic Technology Co., Ltd. Registration: 3043729119 View Registration
CPMT LASER USA LLC Registration: 3044175602 View Registration
RISU MEDICAL TECHNOLOGY CO., LTD. Registration: 3044905918 View Registration
Xi'an Taibo Laser Beauty Company Registration: 3044995573 View Registration
VOMED VOLZER MEDIZINTECHNIK GMBH & CO.KG Registration: 8010349 View Registration
ZIMMER MEDIZINSYSTEME GMBH Registration: 8010720 View Registration
MEDART ApS Registration: 8021543 View Registration
BIOMETRIX LTD. Registration: 8030115 View Registration
NIDEK CO., LTD. Registration: 8030392 View Registration
PERIMED AB Registration: 8030885 View Registration
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Registration: 8030987 View Registration
VTech Communications Ltd Registration: 8040564 View Registration
MOOR INSTRUMENTS LTD. Registration: 8043564 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
HGR INSTRUMENTE GMBH Registration: 8044098 View Registration
KARL STORZ SE & CO. KG Registration: 9610617 View Registration
THE YOSHIDA DENTAL MFG. CO., LTD. Registration: 9611036 View Registration
DORNIER MEDTECH GMBH Registration: 9611388 View Registration
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Registration: 9611516 View Registration
ENRAF-NONIUS B.V. Registration: 9612147 View Registration
EDAP TMS France SA Registration: 9612448 View Registration
FOTONA D.O.O. Registration: 9613462 View Registration
SIRONA DENTAL SYSTEMS GMBH Registration: 9614977 View Registration
Carl Zeiss Meditec AG (Jena) Registration: 9615030 View Registration
Boston Scientific Limited Registration: 9616684 View Registration
QUANTEL MEDICAL Registration: 9680671 View Registration
Boston Scientific Limited Registration: 9681260 View Registration
WAVELIGHT GmbH Registration: 9710340 View Registration

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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-0025-2018

Recall Parameters & Description

Related Establishments / Registrations

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