Skip to content

Ingenia recallZ-1796-2021 · Philips North America Llc · initiated Apr 23, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1796-2021
Status
Open, Classified
Initiated by the company
Apr 23, 2021
Posted by the FDA
Jun 4, 2021
Recalling firm
Philips North America Llc
Quantity
156 MR systems
Product code
LNH
FDA submissions
K181479
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.

Product description

Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 87962).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page