What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

Recall Record: Class I Recall: Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Here's the summary: FDA classified a recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. as Class I, reported 20250226. The affected product is Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). (recall number Z-1161-2025). Reason for recall: Possibility of the patient falling from the table related to the mattress used on the patient table.. Status: Ongoing. 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.

Key facts

Recalling firm	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
Classification	Class I
Recall number	Z-1161-2025
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Possibility of the patient falling from the table related to the mattress used on the patient table.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. 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 MEDICAL SYSTEMS NEDERLAND B.V. 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 MEDICAL SYSTEMS NEDERLAND B.V. 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.

What this classification means

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. 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 I, 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.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.’s FDA history

Argus HQ has recorded 199 total FDA actions tied to PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 199 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
Is Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS recalled?: Yes. FDA lists a Class I recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. for Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY)., reported 20250226, with status "Ongoing." FDA recall number: Z-1161-2025.
What is the recall class for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.'s recall?: FDA classified this recall as Class I. 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.

Know if this happens again — we'll email you.

Free. No spam, just recall alerts for what you tell us to watch.

Full FDA history for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.

APA

Argus HQ Research (2025). Recall Record: Class I Recall: Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/philips-medical-systems-nederland-b-v-z-1161-2025-2025-02-26

MLA

"Recall Record: Class I Recall: Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/recall/philips-medical-systems-nederland-b-v-z-1161-2025-2025-02-26.

Chicago

Argus HQ Research. "Recall Record: Class I Recall: Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/recall/philips-medical-systems-nederland-b-v-z-1161-2025-2025-02-26.

BibTeX

@misc{argushq_argushq_ai_recall_philips_medical_systems_nederland_b_v_z_1161_2025_2025_02_26_2025,
  title = {Recall Record: Class I Recall: Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/philips-medical-systems-nederland-b-v-z-1161-2025-2025-02-26},
  note = {Accessed: July 24, 2026}
}

Source: FDA.gov — Recalls ↗