Home / Recalls / Maquet SAS / Z-2502-2018

Z-2502-2018 Class II Terminated

Recalled by Maquet SAS — Orleans

FDA device recall Z-2502-2018 was initiated by Maquet SAS on June 14, 2018 and is designated Class II. 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 res… The recall status is terminated (terminated June 23, 2022). Affected quantity: 151.

Recall Details

Product Type
Devices
Report Date
July 25, 2018
Initiation Date
June 14, 2018
Termination Date
June 23, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
151

Product Description

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.

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.

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.

Code Information

All Serial Numbers manufactured from March 10, 2014 until November 17, 2016 6.

Other recalls by Maquet SAS

  • Z-2420-2025 Class II — Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (July 14, 2025)
  • Z-1937-2018 Class II — VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June (April 19, 2018)
  • Z-0490-2018 Class II — Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 70106699 (May 22, 2017)
  • Z-0627-2013 Class II — Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Bade (November 2, 2012)
  • Z-2210-2012 Class II — Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehl (May 29, 2012)

FDA data resources