VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP AR

FDA device recall Z-1308-2022 · posted 2022-06-30 · Open, Classified

Recall details

Recalling firm

Getinge Usa Sales Inc

Reason for recall

Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.

Action taken

On May 6, 2022, the firm notified affected customers through an Urgent Medical Device Correction letter. Customers were instructed to continue to perform daily inspections per the IFU, which include checking for any chipped or missing paint. If you observe paint chipping or detachment, the firm recommends that you stop using the device and contact your Getinge service representative to schedule an appointment to replace the part free of charge. The firm is requesting that customers contact their Getinge service representative to have the part replaced if chipped or missing paint is observed through April 2025. Getinge service representatives will inspect the affected component during periodic maintenance and will replace the component if the issue is observed through April 2025.

Root cause

Process change control

Status

Open, Classified

Product code

FSY

Quantity affected

337 (US); 8594 (OUS)

Distribution

Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, GA, IA, ID, KS, KY, LA, MA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, VA, WA.

Date initiated

2022-05-06

Date posted

2022-06-30

Location

Wayne, NJ

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