Philips North America Llc Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
Brand
Philips North America Llc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Philips North America Llc is recalling Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 eye bolts, used as lifting hardware, did not meet the required specification. HOW TO IDENTIFY AFFECTED PRODUCTS Ingenia Ambition X (781356) and Ingenia Ambition S (781359) ACTION TO BE TAKEN BY CUSTOMER / USER No action is required by the customer, as the clinical use of the MR system is not affected. In case of a planned decommissioning or movement of the magnet, and this FCO is not installed yet, please contact your local Philips representative. ACTIONS PLANNED BY PHILIPS Via FCO781 00524 a mechanical solution will be rolled out to the affected MR systems. ***Updated November 2023*** Additional customers were identified and notified on August 22, 2023.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, MI, MO, NH, NJ, NY, PA, SC, TX, VT
Page updated: Jan 10, 2026