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Ingenia Elition S-Magnetic Resonance Medical Electrical… recallZ-2347-2021 · Philips North America Llc · initiated Jul 30, 2021

Terminated

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

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

FDA root cause category: Nonconforming Material/Component

What the company is doing

Philips North America issued U.S. customers letters via certified mail using a 3rd Party service. Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall , health risk and action to take: The Philips Ingenia 1.5T, Ingenia 1.5T Evolution, Ingenia 3.0T, and Ingenia Elition X MR systems can continue to fulfill clinical use as normal. However, in case of technical problems related to off cooling of the magnet, magnet pressure or Helium boil-off, please stop use and contact your local Philips service representative immediately and reference FCO78100530. A Philips Field Service Engineer (FSE) will contact you to schedule an on-site visit to resolve the issue by inspecting the potentially affected system(s) to confirm if the non-conforming pressure relief (42 psi) has been installed (reference FCO78100530). If your system has a 42 psi valve, the Phillips FSE will replace the valve with the correct 3.75 psi valve. you need any further information or support concerning this issue, please contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO78100530.

Recall details

Recall number
Z-2347-2021
Status
Terminated
Initiated by the company
Jul 30, 2021
Recalling firm
Philips North America Llc
Quantity
7 units
Product code
LNH
FDA submissions
K173451
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, United Kingdom.

Product description

Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781357 (OUS)

Code information (models, lots, serial numbers)

S/N and UDI: 46083 (01)00884838088108; 46084 (01)00884838088108; 46086 (01)00884838088108; 46054 (01)00884838088108; 46058 (01)00884838088108; 46082 (01)00884838088108; 46061 (01)00884838088108;

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 88461).

Sources and updates

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