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Ingenia recallZ-1792-2025 · Philips North America Llc · initiated May 13, 2025

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

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDA root cause category: Software design

What the company is doing

On May 12, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users You may continue to use your system(s) in accordance with the intended use. A. To avoid the potential issue of an incorrect cross reference line in MobiView generated images, use the same voxel size and field of view across all station scans. B. Do not use cross reference line functionality in box mode, all slices mode, or 3D mode. Use the cross reference line functionality in single slice mode. Circulate this notice to all users of this device so that they are aware of the issues and associated hazard/harm. Please retain this Urgent Medical Device Correction letter with your system(s) until the software upgrade is installed; ensure the notice is in a place likely to be seen/viewed. Please complete and return the attached response form to Philips MR promptly and no later than 30 days from receipt of this letter via email to: [email protected]. Completing this form confirms receipt of the Urgent Medical Device Correction letter, understanding of the issues, and required actions to be taken. 5. Actions planned by Philips MR to correct the problem A Philips representative will contact you to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the issues (reference FCO78100566, FCO78100584, FCO78100585, FCO78100620, FCO78100621). If you need any further information or support concerning this issue, please contact your local Philips representative. For North America, contact the Customer Care Solutions Center (1-800-722-9377, 8AM-8PM EST, Monday-Friday). This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, or by regular mail, or by fax. For more information, pl

Recall details

Recall number
Z-1792-2025
Status
Open, Classified
Initiated by the company
May 13, 2025
Posted by the FDA
May 16, 2025
Recalling firm
Philips North America Llc
Quantity
13 units (7 US, 6 OUS)
Product code
LNH
FDA submissions
K213516, K230972
Distribution
Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.

Product description

Product Name: Upgrade to MR 7700; Model Number: 782130;

Code information (models, lots, serial numbers)

Model Number: 782130; UDI-DI: 00884838104402; Serial Numbers: 42030, 42066, 42151, 42211, 42248, 42376, 45001, 45007, 45236, 71613, 71907, 85643, 85644;

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 96889).

Sources and updates

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