| | Class 2 Device Recall Philips Allura Xper |  |
| Date Initiated by Firm | September 03, 2025 |
|---|
| Date Posted | October 01, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0008-2026 |
|---|
| Recall Event ID |
97502 |
| 510(K)Number | K041949 K130842 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | Allura Xper FD20 OR Table;
Model Numbers: (1) 722015, (2) 722023, (3) 722035;
Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563; |
|---|
| Code Information |
Model Numbers: (1) 722015, (2) 722023, (3) 722035;
UDI-DI: (1) N/A, (2) 00884838059085, (3) 00884838054240;
Serial Numbers: (1) 12, 2, 16, 8, 23, 3, 13, (2) 27, 116, 12, 175, 98, 35, 72, 142, 179, 46, 64, 110, 124, 66, 117, 109, 42, 138, 83, 82, 127, 75, 118, 41, 146, 33, 165, 121, 3, 169, 101, 103, 129, 10, 105, 90, 107, 100, 47, 159, 137, 119, 164, 70, 95, 177, 2, 158, 86, 34, 132, 9, 108, 31, 112, 173, 114, 170, 172, 4, 14, 85, 13, 88, 25, 67, 94, 87, 57, 125, 73, 106, 16, 96, 58, 99, 38, 141, 32, 84, 68, 134, 79, 52, 56, 69, 37, 21, 53, 123, 157, 102, 126, 145, 144, 15, 135, 152, 149, 60, 150, (3) 243, 123, 38, 85, 101, 117, 212, 21, 172, 183, 252, 236, 88, 57, 143, 125, 145, 161, 244, 119, 100, 165, 47, 126, 127, 52, 247, 131, 124, 89, 169, 46, 245, 246, 242, 74, 30, 192, 60, 59, 196, 216, 187, 121, 34, 222, 72, 111, 128, 227, 174, 144, 28, 84, 130, 263, 132, 25, 98, 134, 35, 226, 190, 3, 6, 1, 249, 109, 251, 232, 207, 158, 160, 237, 163, 79, 248, 253, 94, 80, 250, 154, 69, 97, 148, 170, 195, 26, 122, 96, 107, 142, 58, 166, 235, 230, 265, 83, 53, 32, 164, 56, 40, 11, 10, 62, 221, 257, 255, 229, 256, 254, 261, 260, 238, 113, 258, 241, 188, 259, 267, 167, 204, 43, 33, 37, 104, 233, 114, 108, 153, 70, 65, 191, 77, 110, 225, 75, 76, 193, 185, 186, 129, 103, 71, 92, 151, 201, 208, 149, 205, 19, 50, 51, 61, 211, 99, 12, 15, 198, 82, 105, 136, 194, 23, 200, 116, 48, 13, 106, 95, 206, 168, 203, 146, 81, 156, 45, 173, 49, 64, 171, 184, 102, 17, 215, 29, 231, 16, 202; |
Recalling Firm/
Manufacturer |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
|
Manufacturer Reason
for Recall | The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. |
|---|
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 letter to all users of the system so that they are aware of the issue.
2. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative.
3. Keep this Urgent Medical Device Correction letter 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 to be taken by recalling firm:
1. Philips will replace the BIOS battery in all affected systems.
2. Philips expects to start the implementation of this action in affected devices by November 2025. Your local Philips representative will contact you to schedule a visit to perform this activity in your system once available.
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 | 298 units (72 US, 226 OUS) |
|---|
| Distribution | Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Ukraine, United Arab Emirates, 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
|
|---|
|
|
|
