| | Class 2 Device Recall Philips Allura Xper |  |
| Date Initiated by Firm | September 03, 2025 |
|---|
| Date Posted | September 25, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2633-2025 |
|---|
| Recall Event ID |
97501 |
| 510(K)Number | K102005 K130638 K130842 K133292 K141979 K161563 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | Allura Xper FD20/15;
Product Code: 722058;
Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949; |
|---|
| Code Information |
Product Code: 722058;
UDI-DI: 00884838059115;
Serial numbers: 249, 22, 71, 85, 138, 24, 167, 168, 129, 149, 259, 134, 38, 56, 61, 99, 59, 109, 100, 124, 94, 23, 111, 110, 108, 32, 161, 89, 18, 19, 409, 66, 55, 40, 72, 15, 9, 25, 81, 119, 60, 164, 7, 101, 106, 145, 136, 137, 76, 112, 130, 45, 144, 64, 79, 29, 21, 16, 10, 90, 70, 153, 34, 43, 31, 75, 20, 63, 117, 73, 116, 148, 95, 68, 139, 67, 93, 354, 58, 115, 154, 92, 142, 256, 128, 141, 78, 183, 125, 126, 143, 170, 30, 11, 127, 27, 97, 48; |
Recalling Firm/
Manufacturer |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
|
Manufacturer Reason
for Recall | Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available. |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | On September 3, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken:
1. "Circulate this Urgent Medical Device Correction to all users of the system so that they are aware of the issue and follow the instructions included in the letter.
2. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction to that organization and inform Philips about this transfer through your local Philips representative.
3. Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed.
4. Complete and return the response form included in this Urgent Medical Device Correction to Philips promptly and no later than 30 days from receipt.
5. If you experience the issue described in this letter, please report it to your local Philips representative.
Actions Planned by Recalling Firm:
1. Philips will be replacing the Geo PC in all affected systems.
2. Philips expects to start replacing the Geo PC units by September 2025. Your local Philips representative will contact you to schedule a visit to confirm if your system has a model Wolfdale (Q35 generation) Geo PC and to plan the replacement of the Geo PC once available.
3. If you need additional information or support concerning these issues, contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center). |
|---|
| Quantity in Commerce | 98 units (23 US, 75 OUS) |
|---|
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
|
|---|
|
|
|
