Key facts
| Recalling firm | PHILIPS MEDICAL SYSTEMS |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Philips Spectral CT on Rails. Model Number: 728334. |
| Classification | Class II |
| Recall number | Z-1825-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out. |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is PHILIPS MEDICAL SYSTEMS and the affected product is described in FDA's record as: Philips Spectral CT on Rails. Model Number: 728334.. FDA's stated reason for the recall is: Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-1825-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Philips Spectral CT on Rails. Model Number: 728334. -- and the recall number Z-1825-2026. If it matches, stop using or distributing it and contact PHILIPS MEDICAL SYSTEMS or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
PHILIPS MEDICAL SYSTEMS’s FDA history
Argus HQ has recorded 11 total FDA actions tied to PHILIPS MEDICAL SYSTEMS: 0 warning letters, 11 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Philips Spectral CT on Rails. Model Number: 728334.) and recall number Z-1825-2026, then follow PHILIPS MEDICAL SYSTEMS's recall instructions.
- Has PHILIPS MEDICAL SYSTEMS had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 11 total FDA actions tied to PHILIPS MEDICAL SYSTEMS, including 11 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-1825-2026.
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Related enforcement actions
Full FDA history for PHILIPS MEDICAL SYSTEMS- Recall: PHILIPS MEDICAL SYSTEMS — Class II recall: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Ch… →
- Recall: PHILIPS MEDICAL SYSTEMS — Class II recall: IQon Spectral CT IQon Spectral CT Upgrades →
- Recall: PHILIPS MEDICAL SYSTEMS — Class II recall: Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Prem… →
- Recall: PHILIPS MEDICAL SYSTEMS — Class II recall: Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1… →
- Recall: PHILIPS MEDICAL SYSTEMS — Class II recall: Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versi… →
- Recall: PHILIPS MEDICAL SYSTEMS — Class II recall: Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versio… →
- Recall: PHILIPS MEDICAL SYSTEMS — Class II recall: CombiDiagnost R90 1.0 (709030) →
- Recall: PHILIPS MEDICAL SYSTEMS — Class II recall: CombiDiagnost R90 1.1 (709031) →
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Recall Database: Class II Recall: Philips Spectral CT on Rails. Model Number: 728334. by PHILIPS MEDICAL SYSTEMS. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-philips-medical-systems-z-1825-2026
"FDA Recall Database: Class II Recall: Philips Spectral CT on Rails. Model Number: 728334. by PHILIPS MEDICAL SYSTEMS." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-philips-medical-systems-z-1825-2026.
Argus HQ Research. "FDA Recall Database: Class II Recall: Philips Spectral CT on Rails. Model Number: 728334. by PHILIPS MEDICAL SYSTEMS." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/recall/fda-recall-philips-medical-systems-z-1825-2026.
@misc{argushq_argushq_ai_recall_fda_recall_philips_medical_systems_z_1825_2026_2026,
title = {FDA Recall Database: Class II Recall: Philips Spectral CT on Rails. Model Number: 728334. by PHILIPS MEDICAL SYSTEMS},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-philips-medical-systems-z-1825-2026},
note = {Accessed: August 29, 2026}
}Source: FDA.gov — Recalls ↗