GETINGE US SALES LLC recalls VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD5688119…

Recall date

February 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1349-2018

FDA classification

Class II

Brand / firm

GETINGE US SALES LLC

Sold / distributed

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, Brazil, Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Es…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.