Recall Z-1795-2021 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips North America Llc
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
| Date | Jun 4, 2021 (initiated Apr 23, 2021) |
| Status | Open, Classified |
| Reason | The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet. |
| Root cause | Device Design |
| Action | On March 23, 2021, Philips issued an Urgent Medical Device Correction notice to customers via letter stating Philips identified an issue with specified MR systems. The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities A mechanical issue was detected on these hoisting interface blocks on top of the magnet. In the initial design of the hoisting blocks, the diameter to meet the required bolt-on interface surface for the swivel |
| Quantity | 156 MR Systems |
| Distribution | Domestic: FL, GA, MI, MO, NH, NJ, NY, PA, SC, TX, VT. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Denmark, Finland, France, Germany, Iraq, Italy, Japan, Libya, Moldova, Netherlands, Oman, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181479 | Ingenia Ambition S and Ingenia Ambition X Philips Medical Systems Nederland B.V., Aug 3, 2018 |