Terminated

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.

FDA Recall Z-2502-2018 · Posted None

Recalling FirmMaquet SAS

Recall StatusTerminated

Product CodeFTD

Date Initiated2018-06-14

Date Terminated2022-06-23

Product Quantity151

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130513VOLISTA 400; VOLISTA 600Maquet S.A.S. · 2013-05-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.