Maquet VOLISTA StandOP Surgical Lights recallZ-1860-2019 · Maquet Cardiovascular Us Sales, Llc · initiated May 28, 2019
Class II Terminated All recalls posted in June 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular Us Sales, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1860-2019
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 28, 2019
- Posted by the FDA
- Jun 21, 2019
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Quantity
- 11 units
- Product code
- FTD
- FDA submissions
- K130513
- 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 description
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
Code information (models, lots, serial numbers)
Serial Numbers: 500017 500018 500019 500020 500021 500022 500024 500027 500028 500029 500030
Other devices under the same FDA submission
53 devices cleared under K130513 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ROLITE VOLISTA STANDOP ARDROL309022AMaquet Sas · Light, surgical, ceiling mounted2 recalls0 reports
- ROLITE VOLISTA STANDOP ARDROL309018AMaquet Sas · Lamp, surgical2 recalls0 reports
- ROLITE VOLISTA STANDOP ARDROL309023AMaquet Sas · Lamp, surgical2 recalls0 reports
- STANDOP VOLISTA® ARDVST229003AMaquet Sas · Light, surgical, ceiling mounted1 recall2 reports
- STANDOP VOLISTA® ARDVST229002AMaquet Sas · Light, surgical, ceiling mounted1 recall2 reports
- STANDOP VOLISTA® ARDVST229037AMaquet Sas · Lamp, surgical1 recall1 report
- ROLITE VOLISTA ACCESS ARDROL309024AMaquet Sas · Light, surgical, ceiling mounted1 recall0 reports
- ROLITE VOLISTA ACCESS ARDROL309028AMaquet Sas · Light, surgical, ceiling mounted1 recall0 reports
- ROLITE VOLISTA ACCESS ARDROL309025AMaquet Sas · Lamp, surgical1 recall0 reports
- ROLITE VOLISTA ACCESS ARDROL309029AMaquet Sas · Light, surgical, ceiling mounted1 recall0 reports
- ROLITE VOLISTA STANDOP ARDROL309016AMaquet Sas · Lamp, surgical1 recall0 reports
- ROLITE VOLISTA STANDOP ARDROL309017AMaquet Sas · Lamp, surgical1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 82978).
- Z-1852-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
- Z-1853-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
- Z-1854-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
- Z-1855-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
- Z-1856-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
- Z-1857-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
- Z-1858-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
- Z-1859-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
- Z-1861-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
- Z-1862-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
- Z-1863-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
- Z-1864-2019 · TerminatedMaquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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