FDAClass IIJanuary 24, 2024

Maquet Volista recall

Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP…

Why was Maquet Volista recalled?

A potential for a light system to fall in the operating room.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All systems affected UDI-DI: 03700712400798 03700712400804 03700712400811 03700712400828 03700712400835 03700712400842 03700712400859 03700712400866 03700712400873 03700712400880 03700712400897 03700712400903

Product
Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP…
Recalling firm
Getinge Usa Sales Inc
Quantity
236793 units in total
Distribution
US Nationwide. Global Distribution.
Recall date
January 24, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls