Recall Z-2502-2018 ยท FTD Lamp, Surgical
Maquet SAS
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
| Date | Jun 14, 2018 |
| Status | Terminated |
| Reason | 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 | 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 VOLIST |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130513 | VOLISTA 400; VOLISTA 600 Maquet S.A.S., May 8, 2013 |