FDA Class II Recall: Big Bore RT with software version V4.8.0.10421- Model:… by Philips North America Llc — Recall Details

Key facts

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy. should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Philips North America Llc. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Philips North America Llc should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Philips North America Llc directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Philips North America’s FDA history

Argus HQ has recorded 355 total FDA actions tied to Philips North America: 0 warning letters, 355 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the recall class for Philips North America Llc's recall?

FDA classified this recall as Class II. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Why was Big Bore RT with software version V4.8.0.10421- Model: 72824 recalled?

FDA's recall record states the reason as: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

Who should I contact about this recall?

Contact Philips North America Llc directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Philips North America Llc had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 355 total FDA actions tied to Philips North America Llc, including 355 recalls and 0 warning letters.

Related enforcement actions

• Recall: Philips North America Llc — Class II recall: Spectral CT; Product Code (REF): 728333; →
• Recall: Philips North America Llc — Class II recall: Spectral CT 7500 on Rails; Product Code (REF): 728334; →
• Recall: Philips North America Llc — Class II recall: IQon Spectral CT; Product Code (REF): 728332; →
• Recall: Philips North America Llc — Class II recall: Brilliance iCT; Product Code (REF): 728306; →
• Recall: Philips North America — Class II recall: Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW… →
• Recall: Philips North America — Class II recall: SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with S… →
• Recall: Philips North America — Class II recall: Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. M… →
• Recall: Philips North America — Class II recall: Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR syst… →