Z-1756-2024Class II

The Oncology Essentials Package of the Spectral CT imaging system

Name: Z-1756-2024 The Oncology Essentials Package of the Spectral CT imaging system
Creator: Philips North America Llc
Published: 2024-03-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2024-03-29 / Open, Classified

FDA source

Philips North America Llc began a recall of The Oncology Essentials Package of the Spectral CT imaging system on 2024-03-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1756-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-29
Posted: 2024-05-02
Recalling firm: Philips North America LLC
Product: The Oncology Essentials Package of the Spectral CT imaging system.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 12 units
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 codes and lots: Model No. 728333; UDI: (01)00884838101111(21); Serial No. 10069, 10084, 10169, 10137, 10163, 10196, 10181, 10199, 10210, 10206, 10202, 10139.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1756-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1756-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-08	2024-05-02

Product code JAK

K203020Class IISpectral CTPhilips Medical Systems Nederland B.V. / cleared 2021-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)