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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet

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  Class 2 Device Recall Maquet see related information
Date Initiated by Firm May 28, 2019
Date Posted June 21, 2019
Recall Status1 Open3, Classified
Recall Number Z-1853-2019
Recall Event ID 82978
510(K)Number K130513  
Product Classification Lamp, surgical - Product Code FTD
Product Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811910
Model:VLT600SF STP
Code Information Serial Numbers:  28004 31006 31065 31066 31067 31068 31071 35010 35012 35044 35045  
Recalling Firm/
Manufacturer
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact
973-709-7000
Manufacturer Reason
for Recall
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
FDA Determined
Cause 2
Device Design
Action Getinge/Maquet SAS issued on 5/28/19 Urgent Medical Correction letter via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD). Letter provides identification of issue, health risk and action to take: Before using the VOLISTA StandOP, please inspect the forks and check if cracks on the coating are visible as instructed in the VOLISTA StandOP manual; If a coating crack is detected, please STOP USING the VOLISTA StandOP and contact your Getinge representative. Complete and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM . Return the completed form to Maquet/Getinge by e-mailing a scanned copy to VOLISTAFork2019@getinge.com or by faxing the form to 1-707-202-7275;A Getinge Sales or Service representative will contact you to schedule inspection and correction if necessary of the VOLISTA StandOP SURGICAL LIGHTS at your facility. For technical questions, contact Technical Support Department at 1-888-627-8383 (press option 3 then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. ***Updated 3/30/2020*** On March 30, 2020, the firm sent an new letter to customers, informing them of an update to the corrective actions previously communicated. The firm has developed an interim solution for affected devices. The solution consists of a validated adhesive strip that is resistant to mechanical stresses and compatible with typical chemical agents used in the operating rooms. The solution allows customers to continue using their lights until their defective forks are replaced. The interim solution will be applied by a Getinge representative. A Getinge Sales or Service representative will contact customers to schedule inspection and correction (if necessary) of affected devices at each facility. If your site has already been contacted to schedule an inspection, the work above will be performed during that scheduled visit.
Quantity in Commerce 11 units
Distribution Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FTD and Original Applicant = MAQUET SAS
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