FDAClass IIJanuary 16, 2019

Ingenia Elition S recall

Ingenia Elition S, Ingenia Elition X

Why was Ingenia Elition S recalled?

During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.

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?

Software version R5.5.0 Serial numbers: 45027 45011 45010 45024 45032 45026 45054 45035 45051 45052 45007 45043 45044 45031 45039 45025 46001 45033 45050 45034 45049 45037 45048 46004 45046 45008 45058 45028 45029 45030 45042 46005 46011 45040 45045

Product
Ingenia Elition S, Ingenia Elition X
Recalling firm
Philips Medical Systems Nederlands
Quantity
35
Distribution
CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.
Recall date
January 16, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls