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Incisive CT recallZ-1871-2024 · Philips North America Llc · initiated Apr 15, 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 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

Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity

FDA root cause category: Under Investigation by firm

What the company is doing

Philips issued URGENT Medical Device Correction Letter on 4/15/24 to US consignees. [International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements]. Letter states reason for recall, health risk and action to take: " Please continue to use your system in accordance with its intended use. If you need to remain in the room for the duration of a scan, Philips recommends using protective eyewear. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until a solution is installed on your system; ensure the letter is in a place likely to be seen/viewed. " Place this URGENT Medical Device Correction Letter with your system documentation. " Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken . Philips will contact you to schedule a time for a Field Service Engineer (FSE) to visit your site and install a solution to address the issue (reference FCO72800819 and FCO72800820). If you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377).

Recall details

Recall number
Z-1871-2024
Status
Open, Classified
Initiated by the company
Apr 15, 2024
Posted by the FDA
May 20, 2024
Recalling firm
Philips North America Llc
Quantity
18 units
Product code
JAK
FDA submissions
K180015
Distribution
Worldwide - US Nationwide distribution.

Product description

Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143

Code information (models, lots, serial numbers)

UDI-DI: (01) 00884838085015 (21) + Serial number Serial Numbers- Applied to FCO72800819: 500046, 500064, 500074, 500102, 500110, 500111, 500145, 500168, 500178, 500211 500216, 500217, 500222, 500225, 500230, 500240, 500242. Serial Number-Applied to FCO72800820 : 500615

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 94536).

Sources and updates

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