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Terminated

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.

FDA Recall Z-1937-2018 · Posted None

Recalling FirmMaquet SAS
Recall StatusTerminated
Product CodeFTD
Date Initiated2018-04-19
Date Terminated2020-11-18
Product Quantity187

Reason for Recall

Potential keypad failure on VOLISTA StandOP Surgical Lights.

Firm Action

The firm, Getting, sent "Urgent Medical Device Recall Notice" letters was issued April 19, 2018 and April 24, 2018 via 2 Day Fedex with customer signature required to allow for tracking of delivery. The letter includes a customer response form requesting feedback including if the device is still in use at the facility via FAX BACK TO: 1-585-486-5605 or EMAIL TO: [email protected]. The letter instructs the customer to contact Getinge Service to schedule a visit and replacement by a trained Getinge technician at no charge to the customer. In addition Getinge Service will proactively contact affected customers and replace affected control keypads on VOLISTA StandOP lights when identified. Customers with questions may contact Getinge Customer Support at (800) 950-9912 (select option 1). Customer Service hours: 8:00 AM and 5:00 PM (EST) Monday to Friday.

Root Cause

Device Design

Distribution Pattern

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).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130513VOLISTA 400; VOLISTA 600Maquet S.A.S. · 2013-05-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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