Lower risk Medical device recall · FDA · Published June 11, 2018

Philips Centron Imaging Products: Shutter Reset Risk in Procedures

Philips Healthcare recalls Centron imaging products for potential shutter reset during procedure changes, affecting vascular and cardiac imaging. Users should check model numbers and contact Philips for guidance.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2500-2018Medical device Philips Healthcare ›

Lower-risk recall

The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.

Take action

Contact the company

Recalling firmPhilips Healthcare3000 Minuteman Rd · Andover, MA 01810-1032

✎ GovInfoNow plain-language explainer

Philips Healthcare is recalling certain Centron imaging products used in vascular, cardiovascular, and neurovascular procedures. The issue could cause the shutter to reset to an open position when changing procedure types during an exam, potentially affecting patient safety. Read more at govinfonow.com/recall/70866-philips-centron-imaging-products-shutter-reset-risk-in-procedures.

Source Summary by GovInfoNow · govinfonow.com/recall/70866-philips-centron-imaging-products-shutter-reset-risk-in-procedures · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2500-2018

Cite this page

“Philips Centron Imaging Products: Shutter Reset Risk in Procedures.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70866-philips-centron-imaging-products-shutter-reset-risk-in-procedures. Based on FDA recall #Z-2500-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2500-2018%22&limit=1).

The FDA announced on June 11, 2018, that Philips Healthcare is recalling Centron imaging systems due to a software error that may cause shutter positions to reset incorrectly during examinations. The recall affects 459 systems distributed nationwide.

How to tell if you have it

Centron
Centron 1.0.10
Centron 1.0.10.1
Centron 1.0.10.5

The hazard

According to the FDA, if an operator selects a new procedure type during a single examination, the shutter position resets to the open position for that new type. Settings changed previously during the examination are not retained after this first change of procedure type.

Context

GovInfoNow's records show Philips Healthcare has issued six other recalls since December 21, 2018. Other recent recalls of similar products include Philips Incisive CT Software 5.0 (2023-08-02), Philips StentBoost Live R2.0 (2022-02-02), and Philips Azurion Systems with 2.1(L1) and 2.1(L2) Software (2021-09-24). Additional recent recalls include the Philips MultiDiagnost Eleva (2026-05-18), Philips Brilliance CT 64 Medical Scanner (2026-08-07), and Philips Azurion 7 B20 System (2026-01-26).

How to tell if you have this one

Check for model numbers 1.0.10, 1.0.10.1, or 1.0.10.5 on the product. These Centron imaging products are used in vascular, cardiovascular, and neurovascular procedures like cardiac imaging, interventional procedures, and minimally invasive treatments.

Brand
Philips Healthcare
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide Distribution

Recall number	Product, codes & lots
Z-2498-2018	Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.; Allura 8.1.25 Allura 8.1.25.1 Allura 8.1.25.5 Allura 8.2.25 Allura 8.2.25.5 Allura 8.2.27
Z-2499-2018	UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.; UNIQ 1.0.10 UNIQ 1.0.10.5
Z-2500-2018	Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures.; Centron 1.0.10 Centron 1.0.10.1 Centron 1.0.10.5

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Identify if your Centron imaging product has model numbers 1.0.10, 1.0.10.1, or 1.0.10.5.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 6.1 years after the firm started it.

Jun 11, 2018Firm started the recall
Jul 24, 2018FDA classified it Class II
Aug 1, 2018Published in FDA’s Enforcement Report
Jul 3, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/70866-philips-centron-imaging-products-shutter-reset-risk-in-procedures">Philips Centron Imaging Products: Shutter Reset Risk in Procedures (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2500-2018 (June 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2500-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.