Z-1864-2014Class II

Ingenia 3.0T, magnetic resonance imaging system

Name: Z-1864-2014 Ingenia 3.0T, magnetic resonance imaging system
Creator: Philips Medical Systems, Inc.
Published: 2014-06-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-06-13 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems, Inc. began a recall of Ingenia 3.0T, magnetic resonance imaging system on 2014-06-13. FDA classified it as Class II and gives the reason as "For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1864-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-13
Posted: 2014-06-24
Terminated: 2016-01-27
Recalling firm: Philips North America LLC
Product: Ingenia 3.0T, magnetic resonance imaging system.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On June 14, 2014, Field Safety Notice (FSN 78100432), was be sent to all US and Canadian consignees via certified mail. Philips Key Market representatives will distribute the letter internationally. The FSN instructs consignees to not let hospital technical staff or any person other than Philips service engineers dismount the rear covers before the system is inspected and/or corrected by Philips. Philips has alerted installation and service engineers to this hazard. A Field Change Order with reference FCO781 00432 is being released directing Philips field service engineers to inspect the Ingenia rear cover set nuts and replace them if needed with non-magnetic stainless steel nuts. For further information or support concerning this issue, consignees should contact their local Philips representative at 1-800-722-9377.
Quantity in commerce: 18
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.
Product codes and lots: Model Number: 781377

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1864-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1862-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24
Z-1863-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24
Z-1864-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24
Z-1865-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-24

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)