Z-0694-2019Class II

Ingenia Elition S, Ingenia Elition X

Name: Z-0694-2019 Ingenia Elition S, Ingenia Elition X
Creator: Philips Medical Systems Nederlands
Published: 2018-12-03
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2018-12-03 / Terminated

FDA source

Philips Medical Systems Nederlands began a recall of Ingenia Elition S, Ingenia Elition X on 2018-12-03. FDA classified it as Class II and gives the reason as "During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0694-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-03
Posted: 2019-01-08
Terminated: 2020-05-12
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Ingenia Elition S, Ingenia Elition X
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.
FDA root cause: Under Investigation by firm
Action: On December 4, 2018, the firm notified customers of the recall via an Urgent Medical Device Correction letter. The letter informed customers of the product issue. Customers were asked to do the following: The user must follow the Instructions for Use to verify that no part of the patient's body, hair, clothing, cables or infusion lines can get trapped or injured by any part of the equipment. Additionally, the VitalScreen shows positioning guidance regarding arm supports and padding. The user should avoid the use of the yellow Stop Table button on the VitalScreen. The user must always use the tumble switch or physical Emergency Table Stop button for cases which require the table movement to stop. Philips stated they would be rolling out FCO78100490 Service Pack 1 for R5.5.0 to affected systems. The Service Pack will remove the "Stop Table" software button on the VitalScreen.
Quantity in commerce: 35
Distribution: CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0694-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0694-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-16	2019-01-08

Product code LNH

K173356Class IIIngenia Elition S and Ingenia Elition X R5.4Philips Medical Systems Nederland B.V. / cleared 2018-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)