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

Recalled June 6, 2018 · FDA recall Z-1937-2018 · Maquet SAS

Hazard

Potential keypad failure on VOLISTA StandOP Surgical Lights. · FDA Class II

Units

187

Sold at

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, TR, TT, TW, TZ, YE, ZA, ZW).

Description

Potential keypad failure on VOLISTA StandOP Surgical Lights.

Product

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.

Manufacturer(s)

Maquet SAS

Made in

France

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →