Class 2 Device Recall VOLISTA StandOP Surgical Light

• Date Initiated by Firm: June 14, 2018
• Create Date: July 19, 2018
• Recall Status: Terminated on June 23, 2022
• Recall Number: Z-2502-2018
• Recall Event ID: 80452
• 510(K)Number: K130513
• Product Classification: Lamp, surgical - Product Code FTD
• 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.
• Code Information: All Serial Numbers manufactured from March 10, 2014 until November 17, 2016 6.
• Recalling Firm/ Manufacturer: Maquet SAS; Parc De Limere; Avenue De La Pomme De Pin; Orleans France
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FTD and Original Applicant = MAQUET SAS