Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 18, 2024
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the re…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips Medical Systems Nederland B.v. recalled Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD1… - a moderate-severity action.
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD1… was recalled by Philips Medical Systems Nederland B.v. in December 18, 2024. Reason: Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not insta…. Check the official notice for the remedy. Verify recall #Z-0676-2025 with the FDA Devices before acting.
The recall
Philips Medical Systems Nederland B.v. issued this moderate-severity FDA Devices recall-Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not insta….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- December 18, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0676-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0676-2025) was formally reported on December 18, 2024, with the manufacturer initiating the action on November 11, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips Medical Systems Nederland B.v. is listed as the recalling firm, operating out of Best. Federal records list the affected scope as 2,782 units.
The documented reason for this recall is: Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems ove… Distribution data in the federal record shows the product reached: Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cze…. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,782 units
Related Recalls
6
3 from same agency
Product description
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
Reason for recall
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0676-2025 |
| Date reported | December 18, 2024 |
| Date initiated | November 11, 2024 |
| Recalling firm | Philips Medical Systems Nederland B.v. |
| Firm location | Best |
| Affected scope | 2,782 units |
| Distribution | Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0676-2025) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.. Recalled by Philips Medical Systems Nederland B.v.. Units affected: 2,782 units.
Why was this product recalled? ▼
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2024. Severity: Moderate. Recall number: Z-0676-2025.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, 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-0676-2025) 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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 18, 2024. 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 July 2026.