Z-1827-2014Class II

Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products)

Name: Z-1827-2014 Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products)
Creator: Philips Medical Systems, Inc.
Published: 2014-05-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-05-15 / Terminated / root cause: design

FDA source

Philips Medical Systems, Inc. began a recall of Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley... on 2014-05-15. FDA classified it as Class II and gives the reason as "Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1827-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-15
Posted: 2014-06-18
Terminated: 2015-08-07
Recalling firm: Philips North America LLC
Product: Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
Root cause tag: design
FDA root cause: Device Design
Action: Philips sent an Urgent Field Safety Notice (FSN78100414) dated May 2014 via certified mail to US and Canadian consignees. Philips Key Market representatives will distribute the letter internationally. The letter identified the affected product, explains the problem, actions that should be taken in order to prevent risks for users, and the actions planned by Philips to correct the problem. On May 31, 2014, Philips released a Field Change Order that requires service engineers to replace the front and rear covers of the Ingenia MR FlexTrak Trolley with new covers with protection bumper that prevents foot clamping. For further information and support concerning this issue, consignees should contact their local Philips representative at 1-800-722-9377.
Quantity in commerce: 5
Distribution: Worldwide Distribution - US (nationwide), Canada, Mexico Australia, Austria, Germany, Belarus, Bulgaria, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Jordan, Korea, Republic of Korea, Netherlands, New Zealand, Norway, Oman, Pakistan, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Product codes and lots: Model Number: 9896 030 1929.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1827-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1826-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-18
Z-1827-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-18

Product code LNH

K110151Class IIAchieva R4 1.5T and Achieva R4 3.0TPhilips Health Care / cleared 2011-03-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)