Philips North America — Patient Information Center iX; Software Version Number: 4.5.0
⚠️ A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 22, 2025
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Canada, Czech Republic, Dominican Rep, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Utd.Arab.Emir.
What's affected?
- Product
- Patient Information Center iX; Software Version Number: 4.5.0
- Lot code
- Model Numbers: (1) 866389, (2) 866390; UDI-DI: (1) 00884838127074, (2) N/A; Serial Numbers: 4Z24-5CKL-P, 0P6C-4TL3-D, 6J58-3LL6-0, 216G-7PGV-E, 0F2U-1BLC-H, 291E-7HJU-A, 1M6W-1UP5-1, 4620-0XNW-5, 4W5R-3FHA-L, 6B73-3ZKP-K, 3E79-49M4-3, 4F6Y-70HU-P, 0128-2WG5-0, 0830-3RLW-W, 097K-7LPC-5, 0D2V-1BLC-8, 120T-17M9-A, 173C-20JM-J, 190B-64MU-U, 1K2J-15LB-P, 1L3T-7KGB-E, 2K06-4ZPR-X, 3916-5DJ6-Z, 3V7H-06MT-E, 412A-2WG5-Y, 4271-2NL7-M, 4Z3L-5PP3-0, 5D0E-3EH3-3, 5E0B-3EH3-D, 5E25-14LG-9, 657X-31N5-L, 6G5U-3FHA-R, 781T-7TJA-B, 7N3U-51MJ-B, 7P31-7NPM-P, 283X-7ZPB-A, 7H77-09GU-Z, 4C59-26K6-P, 4N0L-0FKE-2, 5Y0A-02P6-L, 494H-1CJJ-3, 326G-7PGV-A, 292G-3YNZ-9, 0V2A-6DHP-0, 6354-58M8-C, 4W5B-6JK9-A, 5M7K-0VKT-T, 3401-1FHE-M, 6R30-5BNT-N, 6N2E-7YK1-1, 6R0H-6AMX-T, 107C-62PF-Y, 2X1T-7TJA-H, 1M6G-7PGV-K, 1C4Z-6KKD-H, 0B3Z-2RHR-L, 7H39-3JGK-U, 0M0V-6FKB-5, 793D-41PZ-X, 233G-46MR-V, 782Z-3RLW-D, 5N2B-5YJP-G, 0L5F-0ZNF-J, 4G4N-2LKY-K, 2M48-4XM7-Y, 133W-3UN7-B, 295N-0YG8-Y, 5D7W-00G0-1, 5R78-6CPV-0, 3C79-49M4-9, 3T24-5CKL-A, 6H74-27LY-T, 186W-1UP5-8, 0021-1DNN-P, 0247-7ELE-R, 0D5Y-32PN-A, 0J7W-31N5-2, 0R2W-1VNP-P, 0Y5Z-7FHX-N, 121L-1KG1-M, 1366-7XLV-X, 144W-7RPJ-5, 1472-5WKF-X, 1C19-1MHK-F, 1G0F-69LP-G, 1J5U-5HMV-N, 1P4F-34MB-W, 1P5C-6JK9-D, 212R-6HHJ-P, 221V-7TJA-4, 227N-7JG6-J, 232W-7DL9-G, 2A5X-2PJT-0, 2A75-27LY-3, 2F5J-0JLM-7, 2J19-1MHK-W, 2L16-59N8-M, 2M73-5WKF-U, 2N3V-6YM2-X, 2P6J-7PGV-E, 2Y5M-5AGH-E, 326W-21KC-B, 332M-47P7-Y, 3A29-0CKW-3, 3C0U-7AHH-6, 3C2U-05HF-W, 3E05-4ZPR-U, 3G6H-39G4-Y, 3H1T-22HW-5, 3H5R-5HMV-M, 3H79-09GU-5, 3J2K-2TP9-1, 3W1Y-3CH6-J, 4L7Y-00G0-F, 4M77-1HM0-G, 4N3D-20JM-K, 4R0G-60JV-1, 4V2Z-7NPM-M, 4W08-0UH7-U, 4X6C-1PJ5-J, 4Y08-0UH7-L, 500W-6WNX-A, 594D-0EG2-9, 5U0A-3WPK-C, 5W1G-50P2-N, 5Z6J-3HL1-B, 617W-31N5-F, 637V-7BG9-W, 673T-67ME-B, 686N-3NNV-6, 6D3P-4WMG-A, 6K70-3XNY-W, 6P42-35J4-V, 6U1T-75JN-Y, 771A-2JPY-0, 7F5L-73HZ-3, 7G3A-13JG-L, 7K0P-4AH2-6, 7Z2R-05HF-X, 1J1P-6PKN-T, 4R7H-7LPC-J, 282N-0WPA-X, 5G35-04K8-E, 366L-2XHV-A, 5L7D-2UGW-T, 4N0L-0FKE-2;
Additional details
Model Numbers: (1) 866389, (2) 866390; UDI-DI: (1) 00884838127074, (2) N/A; Serial Numbers: 4Z24-5CKL-P, 0P6C-4TL3-D, 6J58-3LL6-0, 216G-7PGV-E, 0F2U-1BLC-H, 291E-7HJU-A, 1M6W-1UP5-1, 4620-0XNW-5, 4W5R-3FHA-L, 6B73-3ZKP-K, 3E79-49M4-3, 4F6Y-70HU-P, 0128-2WG5-0, 0830-3RLW-W, 097K-7LPC-5, 0D2V-1BLC-8, 120T-17M9-A, 173C-20JM-J, 190B-64MU-U, 1K2J-15LB-P, 1L3T-7KGB-E, 2K06-4ZPR-X, 3916-5DJ6-Z, 3V7H-06MT-E, 412A-2WG5-Y, 4271-2NL7-M, 4Z3L-5PP3-0, 5D0E-3EH3-3, 5E0B-3EH3-D, 5E25-14LG-9, 657X-31N5-L, 6G5U-3FHA-R, 781T-7TJA-B, 7N3U-51MJ-B, 7P31-7NPM-P, 283X-7ZPB-A, 7H77-09GU-Z, 4C59-26K6-P, 4N0L-0FKE-2, 5Y0A-02P6-L, 494H-1CJJ-3, 326G-7PGV-A, 292G-3YNZ-9, 0V2A-6DHP-0, 6354-58M8-C, 4W5B-6JK9-A, 5M7K-0VKT-T, 3401-1FHE-M, 6R30-5BNT-N, 6N2E-7YK1-1, 6R0H-6AMX-T, 107C-62PF-Y, 2X1T-7TJA-H, 1M6G-7PGV-K, 1C4Z-6KKD-H, 0B3Z-2RHR-L, 7H39-3JGK-U, 0M0V-6FKB-5, 793D-41PZ-X, 233G-46MR-V, 782Z-3RLW-D, 5N2B-5YJP-G, 0L5F-0ZNF-J, 4G4N-2LKY-K, 2M48-4XM7-Y, 133W-3UN7-B, 295N-0YG8-Y, 5D7W-00G0-1, 5R78-6CPV-0, 3C79-49M4-9, 3T24-5CKL-A, 6H74-27LY-T, 186W-1UP5-8, 0021-1DNN-P, 0247-7ELE-R, 0D5Y-32PN-A, 0J7W-31N5-2, 0R2W-1VNP-P, 0Y5Z-7FHX-N, 121L-1KG1-M, 1366-7XLV-X, 144W-7RPJ-5, 1472-5WKF-X, 1C19-1MHK-F, 1G0F-69LP-G, 1J5U-5HMV-N, 1P4F-34MB-W, 1P5C-6JK9-D, 212R-6HHJ-P, 221V-7TJA-4, 227N-7JG6-J, 232W-7DL9-G, 2A5X-2PJT-0, 2A75-27LY-3, 2F5J-0JLM-7, 2J19-1MHK-W, 2L16-59N8-M, 2M73-5WKF-U, 2N3V-6YM2-X, 2P6J-7PGV-E, 2Y5M-5AGH-E, 326W-21KC-B, 332M-47P7-Y, 3A29-0CKW-3, 3C0U-7AHH-6, 3C2U-05HF-W, 3E05-4ZPR-U, 3G6H-39G4-Y, 3H1T-22HW-5, 3H5R-5HMV-M, 3H79-09GU-5, 3J2K-2TP9-1, 3W1Y-3CH6-J, 4L7Y-00G0-F, 4M77-1HM0-G, 4N3D-20JM-K, 4R0G-60JV-1, 4V2Z-7NPM-M, 4W08-0UH7-U, 4X6C-1PJ5-J, 4Y08-0UH7-L, 500W-6WNX-A, 594D-0EG2-9, 5U0A-3WPK-C, 5W1G-50P2-N, 5Z6J-3HL1-B, 617W-31N5-F, 637V-7BG9-W, 673T-67ME-B, 686N-3NNV-6, 6D3P-4WMG-A, 6K70-3XNY-W, 6P42-35J4-V, 6U1T-75JN-Y, 771A-2JPY-0, 7F5L-73HZ-3, 7G3A-13JG-L, 7K0P-4AH2-6, 7Z2R-05HF-X, 1J1P-6PKN-T, 4R7H-7LPC-J, 282N-0WPA-X, 5G35-04K8-E, 366L-2XHV-A, 5L7D-2UGW-T, 4N0L-0FKE-2;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 146 units (41 US, 105 OUS).
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