CLASS II Device recall · Reported 3 Jul 2019 · FDA Enforcement Report

Maquet Volista StandOP Surgical Lights- Product recalled

Maquet Cardiovascular Us Sales is recalling Maquet Volista StandOP Surgical Lights, distributed nationwide in the US. The recall was initiated on 28 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 21001, 21002

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1852-2019
FDA event ID: 82978
Recalling firm: Maquet Cardiovascular Us Sales, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2019
FDA classified: 21 Jun 2019
Reported: 3 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Surgical Instruments

Timeline

28 May 2019	Recall initiated by company
21 Jun 2019	Classified by FDA	+24 days
3 Jul 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: 21001, 21002

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

12 other products · FDA event 82978

This product is part of a recall event; the main page for the event is Maquet Volista StandOP Surgical Lights- Product recalled.

Reported	Class	Recall	Company	Reason	Where
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide
3 Jul 2019	CLASS II	Maquet Volista StandOP Surgical Lights- Product recalled	Maquet Cardiovascular Us Sales	Particulate Matter	Nationwide

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