PlainRecalls
CriticalClass IOngoing

FDA Devices recall · Reported February 26, 2025

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

Possibility of the patient falling from the table related to the mattress used on the patient table.

Recall #
Z-1142-2025
Affected scope
2,274 units (459 US, 1815 OUS)
Initiated
January 13, 2025
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Philips Medical Systems Nederland B.v. recalled Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, — a critical-severity action.

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, was recalled by Philips Medical Systems Nederland B.v. in February 26, 2025. Reason: Possibility of the patient falling from the table related to the mattress used on the patient table.. Check the official notice for the remedy. Verify recall #Z-1142-2025 with the FDA Devices before acting.

The recall

Philips Medical Systems Nederland B.v. issued this critical-severity FDA Devices recall — Possibility of the patient falling from the table related to the mattress used on the patient table..

Critical
severity level
2K units
affected scope
Class I
classification
February 26, 2025
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1142-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1142-2025) was formally reported on February 26, 2025, with the manufacturer initiating the action on January 13, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Philips Medical Systems Nederland B.v. is listed as the recalling firm, operating out of Best, N/A. Federal records list the affected scope as 2,274 units (459 US, 1815 OUS).

The documented reason for this recall is: Possibility of the patient falling from the table related to the mattress used on the patient table. Distribution data in the federal record shows the product reached: Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Braz…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category — 40,409 medical devices recalls on record

-1,00001,0002,0003,0004,0005,000 20052008201120142017202020232026 1,243

Where this recall sits in the database

Severity2366872097High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.

Severity

Critical

Affected scope

2,274 units (459 US, 1815 OUS)

Related Recalls

6

6 from same agency

Product description

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

Reason for recall

Possibility of the patient falling from the table related to the mattress used on the patient table.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Ongoing
Recall number Z-1142-2025
Date reported February 26, 2025
Date initiated January 13, 2025
Recalling firm Philips Medical Systems Nederland B.v.
Firm location Best, N/A
Affected scope 2,274 units (459 US, 1815 OUS)
Distribution Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussala…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

2,274 units (459 US, 1815 OUS) units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1142-2025) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting — recall details can be updated.
  • This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,. Recalled by Philips Medical Systems Nederland B.v.. Units affected: 2,274 units (459 US, 1815 OUS).
Why was this product recalled?
Possibility of the patient falling from the table related to the mattress used on the patient table.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 26, 2025. Severity: Critical. Recall number: Z-1142-2025.
Where was the recalled product distributed?
Distribution: Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-1142-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported February 26, 2025.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.