—#206995

Product

The Oncology Essentials Package of the Spectral CT imaging system.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K203020
Affected lot / code info: Model No. 728333; UDI: (01)00884838101111(21); Serial No. 10069, 10084, 10169, 10137, 10163, 10196, 10181, 10199, 10210, 10206, 10202, 10139.

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: Worldwide distribution - US Nationwide in the states of AZ, HI, MN, VT, WV and the countries of China, Macao, New Zealand, Portugal, Switzerland.

Timeline

Recall initiated: 2024-03-29
Posted by FDA: 2024-05-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206995. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.