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Ingenia recallZ-0956-2024 · Philips North America · initiated Jan 3, 2024

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 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 Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDA root cause category: Process control

What the company is doing

On January 4, 2024, the firm began notification of affected customers via URGENT Medical Device Correction letters. Customers were provided with precautions to take when using the device, including inspection of the QBC seal for separation. If the QBC seal is found to be loose, or becomes loose during a patient scan, customers should immediately stop use and contact their local Philips service representative. Customers should also ensure that all users of the device are aware of the issue and retain the letter with affected systems until a solution is installed. Philips will contact customers to schedule a time for a Field Service Engineer (FSE) to visit your site and replace your system's QBC Seal. Philips plans to start implementing corrections in Q3 2024. 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). Revision B of the URGENT Medical Device Correction letter was distributed to the additional US consignees on 24-Mar-2025. It was later identified that UMDC Rev B contained three MR systems with a 70cm bore (Ingenia 1.5T: 781341, Ingenia 3.0T: 781377, Ingenia Ambition X: 782109) which were incorrectly included, as the scope of this field action is MR systems with 60cm bore. The URGENT Medical Device Correction letter was updated to Rev C to remove these systems. Revision C of the UMDC was distributed to the additional US consignees on 09-Apr-2025.

Recall details

Recall number
Z-0956-2024
Status
Open, Classified
Initiated by the company
Jan 3, 2024
Posted by the FDA
Feb 1, 2024
Recalling firm
Philips North America
Quantity
21 US; 265 OUS
Product code
LNI
Distribution
Worldwide - US Nationwide distribution.

Product description

SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.

Code information (models, lots, serial numbers)

a. Model No. 781270; UDI-DI 00884838095083. b. Model No. 782113; UDI-DI 00884838098909. c. Model No. 782129; UDI-DI 00884838105805. All units affected

Devices named in this recall

3 devices 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 93787).

Sources and updates

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