FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: Ingenia 1.5T, magnetic resonance imaging system.
- Recall number
- Z-1865-2014
- Recalling firm
- Philips Medical Systems, Inc.
- Product
- Ingenia 1.5T, magnetic resonance imaging system.
- Status
- Terminated
- Initiated
- 2014-06-13
- Posted
- 2014-06-24
- Terminated
- 2016-01-27
- Reason
- 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
- 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
- 24
- 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.
- Lot, serial or model codes
- Model Number: 781396
- 510(k) numbers
- ["K110151"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28