Recall Z-1349-2018— GETINGE US SALES LLC

Name: FDA recall Z-1349-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-07

Class II · Terminated

Class II FDA medical device recall by GETINGE US SALES LLC, initiated 2018-02-07, terminated 2021-09-02. It names one FDA 510(k) clearance: K130513. Product: 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.. Reason: 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..

Recalling firm: GETINGE US SALES LLC
Classification: Class II
Status: Terminated
Initiated: 2018-02-07
Terminated: 2021-09-02
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K130513 — VOLISTA 400; VOLISTA 600Maquet S.A.S.·cleared 2013-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.