Philips North America Llc Recall 87962
Description: Ingenia Ambition X - Model Number: 781356, Diagnostic MR system.
Philips North America Llc Recall 87962 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1795-2021 |
| Event ID | 87962 |
| Event Description | Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. |
| Product Type | Devices |
| 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. |
| Quantity | 54 MR Systems |
| Recall 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. |
| Device Classification | 20210616 |
| Device Code Info | Serial numbers: 47001 47002 47003 47009 47000 47012 47017 47013 47047 47040 47052 47015 47049 47056 47023 47019 47030 47053 47014 47035 47034 47020 47048 47080 47032 47057 47041 47072 47075 47091 47219 47184 47058 47258 47215 47197 47004 47026 47006 47007 47018 47027 47011 47037 47039 47029 47038 47043 47022 47044 47070 47062 47071 47054 |
| Center Classification Date | 20210604 |
| Recall Initiation Date | 20210423 |
| Recalling Firm | Philips North America Llc |
| Initial Notification | Letter |
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