Z-2502-2018Class II

VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911...

Name: Z-2502-2018 VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911...
Creator: Maquet SAS
Published: 2018-06-14
License: https://open.fda.gov/license/

Maquet SAS / initiated 2018-06-14 / Terminated / root cause: manufacturing process

FDA source

Maquet SAS began a recall of VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP... on 2018-06-14. FDA classified it as Class II and gives the reason as "Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2502-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-14
Posted: 2018-07-19
Terminated: 2022-06-23
Recalling firm: Maquet SAS
Product: VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.
Product code: FTD Lamp, Surgical
Reason for recall: Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from the arm and become suspended only from the cabling inside the arm. Use of an affected device may result in serious injury to patient and/or medical staff if the light head detaches and drops, impacting patient and/or medical staff during demonstration, service, or use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On June 14, 2018, the firm issued an Urgent Medical Device Field Correction letter via FedEx to affected customers. Customers were advised of the potential light head detachment on VOLISTA StandOP Surgical Lights. Customers were instructed to do the following: 1. Ensure that all users were made aware of the recall; distributors were asked to forward the recall letter to their customers' attention for appropriate action. 2. Check your VOLISTA StandOP serial number versus the list of affected devices on page 5 and ensure it is available for a Getinge Service technician visit. 3. Per the VOLISTA Instructions for Use*, Section 11.2 (General Maintenance) - Daily Checks (performed by the user), examine your affected VOLISTA StandOP surgical light immediately. If the bracket in the device is improperly assembled, mechanical play will be observed when the light head is manipulated in a way that is not expected to be encountered in clinical use. Further instructions for testing the device are included in the letter. 4. Complete and sign the enclosed Customer Response Form (Page 5) and return to Getinge using the fax number or email address provided on the form. A Getinge Service person will contact the person you listed on the Customer Response Form to schedule service for an update of your device, free of charge. You can also arrange a visit by a Getinge-trained or authorized service technician by calling Getinge Customer Support at (800) 950-9912 (select option 1). Customer Service hours: 8:00 AM and 5:00 PM (EST) Monday to Friday.
Quantity in commerce: 151
Distribution: Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, KS, KY, LA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, and WA. Foreign distribution to Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Ghana, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Tanzania, Yemen, and Zimbabwe.
Product codes and lots: All Serial Numbers manufactured from March 10, 2014 until November 17, 2016 6.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2502-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2502-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-19

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)