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U.S. Department of Health and Human Services

Class 2 Device Recall VOLISTA

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  Class 2 Device Recall VOLISTA see related information
Date Initiated by Firm April 19, 2018
Create Date May 25, 2018
Recall Status1 Terminated 3 on November 18, 2020
Recall Number Z-1937-2018
Recall Event ID 79898
510(K)Number K130513  
Product Classification Lamp, surgical - Product Code FTD
Product VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL

VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment.
Code Information Serial Numbers: 38013 38016 500641 500644 25002 35025 35028 38012 38015 500000 500001 500003 500004 500014 500015 500016 500018 500037 500039 500020 500060 500063 500642 500643 31053 500058 38009 38026 31002 31030 31048 31054 21001 21002 35024 35012 35013 35014 35015 38017 500001 500017 35029 35017 35027 31019 31020 31022 31024 31025 31026 31000 31000 31001 31002 31003 31006 31009 31010 31012 31008 31047 31050 31051 31052 500002 500060 500061 500072 500073 500680 500685 500686 500687 500692 510082 500062 500064 500042 500044 31012 31013 31014 31020 38011 38014 31006 31008 31015 31016 500068 500070 500071 500074 31021 31023 38018 38019 38020 38021 38022 38023 38024 38025 31004 35011 31004 31017 31018 35000 35001 35018 35019 35020 35021 35022 35023 35026 35030 35031 35032 35033 38027 31001 31003 28003 28004 25005 25006 500055 500059 500011 500013 25007 25004 31039 31040 31041 31042 31043 31044 31045 31046 31055 31056 31005 31009 31011 31017 31019 38025 38026 38027 38028 500065 500066 500067 500069 38000 38002 500002 500005 500010 500012 500056 500059 38001 38003 31031 31049 20502 20503 500075 500076 500609 500610 500611 500612 500613 500614 500615 500616 500617 500618 500619 500620 500066 500067 500068 500069 500070 500071 500072 500073 510007 510008 510009 510010 510011 510012 510013 510014 
Recalling Firm/
Manufacturer
Maquet SAS
Parc De Limere
Avenue De La Pomme De Pin
Orleans France
For Additional Information Contact Barb Smith
585-214-6049
Manufacturer Reason
for Recall
Potential keypad failure on VOLISTA StandOP Surgical Lights.
FDA Determined
Cause 2
Device Design
Action The firm, Getting, sent "Urgent Medical Device Recall Notice" letters was issued April 19, 2018 and April 24, 2018 via 2 Day Fedex with customer signature required to allow for tracking of delivery. The letter includes a customer response form requesting feedback including if the device is still in use at the facility via FAX BACK TO: 1-585-486-5605 or EMAIL TO: VOLISTA_StandOP_Keypad_FA.SW-US@getinge.com. The letter instructs the customer to contact Getinge Service to schedule a visit and replacement by a trained Getinge technician at no charge to the customer. In addition Getinge Service will proactively contact affected customers and replace affected control keypads on VOLISTA StandOP lights when identified. Customers with questions may contact Getinge Customer Support at (800) 950-9912 (select option 1). Customer Service hours: 8:00 AM and 5:00 PM (EST) Monday to Friday.
Quantity in Commerce 187
Distribution Worldwide Distribution: US (nationwide) and countries of: (AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CM, CN, CO, CZ, DE, DK, EC, EE, EG, ES, Fl, FR, GB, GH, HK, HR, HU, IE, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LU, LV, MQ, MX, MY, NA, NG, NL, OM, PA, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, TZ, YE, ZA, ZW).
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FTD and Original Applicant = MAQUET SAS
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