Recall Z-0794-2011 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems North America Co. Phillips
Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit. Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body.
| Date | Dec 21, 2010 (initiated May 12, 2009) |
| Status | Terminated |
| Reason | The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system. |
| Root cause | Nonconforming Material/Component |
| Action | On 05/12/2009, Philips began sending out the URGENT-Field Safety Notice MR Accessory Cart to their consignees. The letter identified the affected product and stated that the drawer rails were made from magnetic material and were not according specification. The hazards involved were also provided along with how to identify the affected product. The firm issued the FCO 78100296 and the firm's Field Service Engineer replaced the magnetic rails with the non-magnetic rails at the consignee's site. The consignees can contact contact the Philips Healthcare Call Center at 800-722-9377 #5 (then |
| Quantity | 3 units |
| Distribution | Nationwide Distribution -- IL, MI, and MD. |
| FDA record | Open on fda.gov |