FDA Device recall Z-1796-2021
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system
- FDA Device
- Class II
- ongoing
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class II recall of Ingenia Ambition S - Model Number: 781359 Diagnostic MR system by Philips North America, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1796-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-23 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | FL, GA, MI, MO, NH, NJ, NY, PA, SC, TX, VT |
Product
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
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.
Identifiers
| code_info | REF 781359/ UDI-DI 00884838090057 Serial numbers: 48000 48001 48003 48004 48009 48005 48015 48017 48020 48011 48022 48…REF 781359/ UDI-DI 00884838090057 Serial numbers: 48000 48001 48003 48004 48009 48005 48015 48017 48020 48011 48022 48012 48014 48028 48026 48037 48023 48043 48019 48160 48144 48180 48112 48052 ***Updated November 2023*** Added Serial Numbers 48051 48010 48038 48018 48039 48027 48122 48046 48036 48047 48133 48056 48169 48148 48154 48055 48128 48194 48173 48134 48040 48155 48186 48035 48181 48188 48198 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1796-2021%22
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