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

Recall date

April 19, 2018

Source

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

Recall number

Z-1937-2018

FDA classification

Class II

Brand / firm

Maquet SAS

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: (AE, AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CM, CN, CO, CZ, DE, DK, EC, EE, EG, ES, Fl, FR, GB, GH, HK, HR, HU, IE, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LU, LV, MQ, MX, MY, NA, NG, NL, OM, PA, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH,…

Why it was recalled

Potential keypad failure on VOLISTA StandOP Surgical Lights.

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 (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, 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.