Philips North America Llc The Oncology Essentials Package of the Spectral CT imaging system. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Oncology Essentials Package of the Spectral CT imaging system.
Brand
Philips North America Llc
Lot Codes / Batch Numbers
Model No. 728333, UDI: (01)00884838101111(21), Serial No. 10069, 10084, 10169, 10137, 10163, 10196, 10181, 10199, 10210, 10206, 10202, 10139.
Products Sold
Model No. 728333; UDI: (01)00884838101111(21); Serial No. 10069, 10084, 10169, 10137, 10163, 10196, 10181, 10199, 10210, 10206, 10202, 10139.
Philips North America Llc is recalling The Oncology Essentials Package of the Spectral CT imaging system. due to Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subseque. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 CTNM.QARA@philips.com. 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026