FDAClass IIJuly 10, 2013

MAQUET Getinge Group Mobile Operating Table YUNO OTN GA recall

MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures…

Why was MAQUET Getinge Group Mobile Operating Table YUNO OTN GA recalled?

MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number 1433.01F0). Identification of the Extension device issue: By fully actuating the lever of the extension device handle, the operator's skin can enter a gap between the handle lever and a recess in the handle bar. When the lever is released,

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

YUNO OTN Mobile Operating Table: 1433.01F0 Extension Device: 1433.62A1

Product
MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures…
Recalling firm
Maquet Cardiovascular Us Sales, Llc
Quantity
13 Tables; 24 Extension devices
Distribution
Worldwide Distribution - USA including Arizona, Georgia, North Dakota, South Carolina, Texas and Tennessee, Internationally to United Arab Emirates, Austria, Brazil, Canada, Switzerland, China, Germany, Spain, France, United Kingdom, Italy, Japan, Singapore, Thailand, Turkey, Serbia, and South Africa.
Recall date
July 10, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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