—#128277

Product

Ingenia 3.0T, magnetic resonance imaging system.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K110151
Affected lot / code info: Model Number: 781377

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-06-13
Posted by FDA: 2014-06-24
Terminated: 2016-01-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128277. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.