Stop using now Medical device recall · FDA · Published November 19, 2021

Philips Allura Xper FD Series: Risk of Monitors Falling Due to Loose Screws

Philips recalls Allura Xper FD series with software version 2.1.x for possible loose set screws causing monitors to fall, risking patient or user harm. Affected models include 722005-722028.

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

🇺🇸 FDA recall #Z-0416-2022Medical device Philips ›

Stop using this now

Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

Philips is recalling its Allura Xper FD series medical imaging devices with software version 2.1.x because set screws holding extra monitors to the ceiling can become loose. If these monitors detach, they could fall and cause injury to patients, users, or service technicians requiring medical attention. Read more at govinfonow.com/recall/61517-philips-allura-xper-fd-series-risk-of-monitors-falling-due.

Source Summary by GovInfoNow · govinfonow.com/recall/61517-philips-allura-xper-fd-series-risk-of-monitors-falling-due · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0416-2022

Cite this page

“Philips Allura Xper FD Series: Risk of Monitors Falling Due to Loose Screws.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61517-philips-allura-xper-fd-series-risk-of-monitors-falling-due. Based on FDA recall #Z-0416-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0416-2022%22&limit=1).

Philips North America Llc recalled Philips Allura Xper FD series medical imaging systems due to the risk of monitor components falling and causing injury, according to the FDA. The agency announced the recall on November 19, 2021.

How to tell if you have it

Brand: Philips
Product: Philips Allura Xper FD series with Software Version Number: 2.1.x-
Model Numbers: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028
UPCs: 00884838054189, 00884838054196, 00884838054202, 00884838059030, 00884838059054, 00884838059191
Distribution: Worldwide; US states of DC, GA, MA, TX, VA; countries of Dominican Republic, India, Japan, Poland, Spain, Taiwan

The hazard

Set screws securing the gliding rods of Extra Monitors can come loose, causing the monitors to disengage from the Mounting Ceiling Suspension structure and fall. This may lead to harm to patients, users, or service engineers that requires medical intervention.

Context

GovInfoNow's records show Philips North America Llc has 129 other recalls on record since July 12, 2017. Other recent recalls of similar products include Evolution upgrade 1.5T and Evolution upgrade 3.0T (August 21, 2026), Spectral CT 7500 Scanner (August 18, 2026), and Ingenuity CT Scanners (August 7, 2026).

How to tell if you have this one

Check for Philips Allura Xper FD series devices with software version 2.1.x. Affected models include 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028. US serial numbers starting with (01)00884838054202(21) or similar patterns.

Brand
Philips
Product
Philips Allura Xper FD series with Software Version Number: 2.1.x
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Device Immediately
Discontinue use of the affected Philips Allura Xper FD series devices with software version 2.1.x until a remedy is provided.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of DC, GA, MA, TX, VA and the countries of Dominican Republic, INDIA, Japan, Poland, Spain, Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: District of Columbia, Georgia, Massachusetts, Texas, Virginia.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Nov 19, 2021Firm started the recall
Dec 22, 2021FDA classified it Class II
Dec 29, 2021Published in FDA’s Enforcement Report
Feb 7, 2024FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/61517-philips-allura-xper-fd-series-risk-of-monitors-falling-due">Philips Allura Xper FD Series: Risk of Monitors Falling Due to Loose Screws (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-0416-2022 (November 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0416-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.