Reported Jun 6, 2018 · Terminated

VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref.…

Maquet SAS

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Maquet SAS · Parc De Limere · Orleans, N/A · N/A

Is this the product you have?

  • VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560
  • Part numbers568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP QL; 568821961, VLT600DF AIM STP QL VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or patient during surgical operations, diagnostics and treatment
Lot codes and dates
  • Serial Numbers

    202 of 202 codes

    • 38013
    • 38016
    • 500641
    • 500644
    • 25002
    • 35025
    • 35028
    • 38012
    • 38015
    • 500000
    • 500001
    • 500003
    • 500004
    • 500014
    • 500015
    • 500016
    • 500018
    • 500037
    • 500039
    • 500020
    • 500060
    • 500063
    • 500642
    • 500643
    • 31053
    • 500058
    • 38009
    • 38026
    • 31002
    • 31030
    • 31048
    • 31054
    • 21001
    • 21002
    • 35024
    • 35012
    • 35013
    • 35014
    • 35015
    • 38017
    • 500001
    • 500017
    • 35029
    • 35017
    • 35027
    • 31019
    • 31020
    • 31022
    • 31024
    • 31025
    • 31026
    • 31000
    • 31000
    • 31001
    • 31002
    • 31003
    • 31006
    • 31009
    • 31010
    • 31012
Amount recalled
187

Where it was sold

Why it was recalled

Potential keypad failure on VOLISTA StandOP Surgical Lights.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 18, 2020 · Data as of Sep 19, 6:51 PM UTC

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