Maquet SAS Parc De Limere Avenue De La Pomme De Pin Orleans France Recalls
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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 room
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.
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.
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagno
Potential keypad failure on VOLISTA StandOP Surgical Lights.
The firm, Getting, sent "Urgent Medical Device Recall Notice" letters was issued April 19, 2018 and April 24, 2018 via 2 Day Fedex with customer signature required to allow for tracking of delivery. The letter includes a customer response form requesting feedback including if the device is still in use at the facility via FAX BACK TO: 1-585-486-5605 or EMAIL TO: VOLISTA_StandOP_Keypad_FA.SW-US@getinge.com. The letter instructs the customer to contact Getinge Service to schedule a visit and replacement by a trained Getinge technician at no charge to the customer. In addition Getinge Service will proactively contact affected customers and replace affected control keypads on VOLISTA StandOP lights when identified. Customers with questions may contact Getinge Customer Support at (800) 950-9912 (select option 1). Customer Service hours: 8:00 AM and 5:00 PM (EST) Monday to Friday.