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Recall Observatory FDA recall evidence

Device product

Ingenia 1.5T R5, magnetic resonance imaging system.

Z-1863-2014

June 13, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 68588
Status
Terminated
Classification
Class II
Quantity
33
Official record key
device-enforcement:Z-1863-2014

Official wording

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.

Code information: Model Number: 781341

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.