Z-1863-2019Class II

Maquet VOLISTA StandOP Surgical Lights-

Name: Z-1863-2019 Maquet VOLISTA StandOP Surgical Lights-
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2019-05-28
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2019-05-28 / Terminated / root cause: design

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF on 2019-05-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1863-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-28
Posted: 2019-06-21
Terminated: 2023-07-10
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
Product code: FTD Lamp, Surgical
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
Root cause tag: design
FDA 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 [email protected] 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: 9 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
Product codes and lots: Serial Numbers: 500003 500004 500005 500006 500007 500010 500011 500012 500013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1863-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1852-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1853-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1854-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1855-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1856-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1857-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1858-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1859-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1860-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1861-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1862-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1863-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21
Z-1864-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-21

Product code FTD

K130513Class IIVolista 400; Volista 600Maquet S.A.S. / cleared 2013-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)