Recall Z-1865-2014 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems, Inc.
Ingenia 1.5T, magnetic resonance imaging system.
| Date | Jun 24, 2014 (initiated Jun 13, 2014) |
| Status | Terminated |
| 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 I |
| 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 Z |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110151 | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T Philips Health Care, Mar 22, 2011 |