Philips Medical Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1864-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Ingenia 3.0T, magnetic resonance imaging system.

Product Classification:

Class II

Date Initiated: June 13, 2014

Date Posted: July 2, 2014

Recall Number: Z-1864-2014

Event ID: 68588

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.

Status: Terminated

Product Quantity: 18

Code Information:

Model Number: 781377

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.

Voluntary or Mandated:

Voluntary: Firm initiated