The Oncology Essentials Package of the Spectral CT imaging… recallZ-1756-2024 · Philips North America Llc · initiated Mar 29, 2024
Open, Classified
Is my device affected?
- 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.
- 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.
- 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 third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
FDA root cause category: Under Investigation by firm
What the company is doing
An URGENT Medical Device Correction Letter, dated 3/27/24, was mailed to consignees to notify them of this recall. Consignees are instructed to identify if a third-party laser was installed on their system and if the laser line is reflected, duplicated, or thickened. If a third-party laser is installed, before treatment of a patient, reposition or re-image as necessary to verify proper placement of the localization laser marks. Systems may continue to be used in accordance with the intended use and provided use recommendations. Consignees are to complete and return the provided response form by email to [email protected]. The provided recall notification is to be disseminated to all users of affected systems. Philips will contact consignees to schedule a time for a Field Service Engineer to visit and install hardware to resolve the issue. Questions are to be directed to the Customer Care Solutions Center at 1-800-722-9377 from 8:00 AM to 8:00 PM, Monday through Friday.
Recall details
- Recall number
- Z-1756-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 29, 2024
- Posted by the FDA
- May 2, 2024
- Recalling firm
- Philips North America Llc
- Quantity
- 12 units
- Product code
- JAK
- FDA submissions
- K203020
- Distribution
- Worldwide distribution - US Nationwide in the states of AZ, HI, MN, VT, WV and the countries of China, Macao, New Zealand, Portugal, Switzerland.
Product description
The Oncology Essentials Package of the Spectral CT imaging system.
Code information (models, lots, serial numbers)
Model No. 728333; UDI: (01)00884838101111(21); Serial No. 10069, 10084, 10169, 10137, 10163, 10196, 10181, 10199, 10210, 10206, 10202, 10139.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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