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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:162696

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 recall number

Z-1349-2018

Evidence summary

Product code
FSY
Recall status
Terminated
Event initiated
February 07, 2018
Root cause
Component design/selection
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1349-2018

Field note

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