FDA-Device2018-04-18Class II
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.
GETINGE US SALES LLC
Hazard
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.
Sold states
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, Estonia, Finland, France, Germany, Ghana, Hong Kong, Hungary, India, Iran, Iraq, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad-Tobago, Turkey, UAE, UK, Yemen and Zimbabwe.
Affected count
5214
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1349-2018Don't want to check this manually?
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