VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD56881191

FDA device recall Z-1349-2018 · posted 2018-04-10 · Terminated

Recall details

Recalling firm

GETINGE US SALES LLC

Reason for recall

The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.

Action taken

The firm, Getinge, sent an "URGENT MEDICAL DEVICE RECALL" Notice dated 2/7/2018 to all affected consignees via mail. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following: 1) Ensure that all users of the device are made aware of this field correction. 2) Check the device serial number against the list of affected serial numbers. 3) Contact the recalling firm to arrange for servicing of all affected units. Getinge Customer Service: (800) 950-9912, 8AM - 5PM (EST) Monday to Friday. 4) Complete and sign the enclosed customer response form, and return it by fax to: (973) 860-1675 or by email to: VolistaLights.FA@getinge.com. If you have any questions, please contact your Getinge representative or call Getinge Customer Service at (800)950-9912 (Select option 1) between 8:00 AM and 5:00 PM (EST).

Root cause

Component design/selection

Status

Terminated

Product code

FSY

Quantity affected

5214

Distribution

Worldwide Distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, ID, IA, KS, KY, ME, MO, NE, NY, OR, TN, TX, UT, and WA; and countries of: Argentina, Australia, Austria, Belgium, Bolivia, Bra

Date initiated

2018-02-07

Date posted

2018-04-10

Date terminated

2021-09-02

Location

Wayne, NJ

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