Maquet Cardiovascular Us Sales, Llc: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

Recall number

Z-1854-2019

Recalling firm

Maquet Cardiovascular Us Sales, Llc

Product

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

Status

Terminated

Initiated

2019-05-28

Posted

2019-06-21

Terminated

2023-07-10

Reason

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

Root cause

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

65 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

Lot, serial or model codes

Serial Numbers:  31000 31001 31002 31003 31004 31006 31008 31009 31010 31012 31017 31018 31019 31020 31021 31022 31023 31024 31025 31026 35000 35001 35011 35012 35013 35014 35015 35017 35018 35019 35020 35021 35022 35023 35024 35025 35026 35027 35028 35030 35031 35032 35033 38000 38001 38002 38003 38009 38011 38012 38013 38014 38015 38016 38018 38019 38020 38021 38022 38023 38025 38026 38027

510(k) numbers

["K130513"]

PMA numbers

not on file

Product code

FTD

Firm FEI

3008355164

Firm city

Wayne

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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