Recall Z-1827-2014 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems, Inc.
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.
| Date | Jun 18, 2014 (initiated May 15, 2014) |
| Status | Terminated |
| Reason | Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF. |
| Root cause | Device Design |
| Action | Philips sent an Urgent Field Safety Notice (FSN78100414) dated May 2014 via certified mail to US and Canadian consignees. Philips Key Market representatives will distribute the letter internationally. The letter identified the affected product, explains the problem, actions that should be taken in order to prevent risks for users, and the actions planned by Philips to correct the problem. On May 31, 2014, Philips released a Field Change Order that requires service engineers to replace the front and rear covers of the Ingenia MR FlexTrak Trolley with new covers with protection bumper that pre |
| Quantity | 5 |
| Distribution | Worldwide Distribution - US (nationwide), Canada, Mexico Australia, Austria, Germany, Belarus, Bulgaria, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Jordan, Korea, Republic of Korea, Netherlands, New Zealand, Norway, Oman, Pakistan, Russian Federation, Singapore, Slovak |
| 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 |