Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Patient Information Center iX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Patient Information Center iXsee related information
Date Initiated by FirmApril 19, 2023
Date PostedOctober 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0035-2025
Recall Event ID 95325
510(K)NumberK113125 K153702 
Product Classification Detector and alarm, arrhythmia - Product Code DSI
ProductPatient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Code Information UDI-DI: 00884838104594; Serial Numbers:0Y5Z-7FHX-N 5H20-1DNN-E 1762-74NU-5 1C0V-08NR-0 6U53-30PD-1 6M5J-0JLM-H 2M2G-15LB-E 4U3A-3JGK-K 0439-16GM-G 3A1T-22HW-U 534U-57JE-Y 0D6U-5ZH1-D 3H5C-6JK9-X 3K0C-3EH3-H 3Z47-12JD-V 524N-43JR-2 5N40-2RHR-N 1331-5BNT-B 1V4F-34MB-G 1B4R-37N1-3 6D3L-28MC-M 7Y52-29H4-L 7Y5Z-7FHX-F 1X6W-21KC-W 6278-09GU-Y 2C6N-3KLU-C 3E5Y-32PN-4 5T2L-2TP9-V 021Z-1WJ2-5 1W6W-21KC-Z 7L3H-46MR-L 194D-2YHB-T 1Y7A-49M4-6 2Z3C-1AHM-3 4T51-53NK-A 1P4A-44NB-V 3B5M-55J9-5 5V57-0HN3-J 7V5Z-7FHX-R 224B-2HJF-F 5G1G-01JC-Z 6Y7F-06MT-0 676T-6XMZ-M 5F1G-01JC-2 5K2B-6DHP-4 5T45-7ELE-C 0V7B-4EJH-A 1F23-36KM-0 2C50-6KKD-R 3107-4RG3-6 3X5B-1NH8-2 6U32-24GX-0 5K2L-2TP9-D 4T2R-6HHJ-D 613L-28MC-T 7K21-0XNW-C 062U-1VNP-B 5M78-09GU-6 6226-14LG-X 0V6R-0PLF-7 5K72-2NL7-J 7G21-0XNW-M 077M-7JG6-L 2R4Y-5JHY-8 7Z4E-0EG2-N 1X2J-6LPP-R 1Y0A-64MU-A 0Z3E-41PZ-K 327Y-2CJW-6 3979-6CPV-0 2150-6KKD-T 4E6Z-70HU-B 1H3G-4UJL-D 2A75-27LY-3 3X3J-5PP3-5 4V7G-0BLD-8 567W-7BG9-5 5K6K-0RGF-L 6F2V-1BLC-W 0106-0UH7-D 1T1M-1TLH-F 5N2E-2FMY-1 057M-7JG6-U 0M5T-3FHA-Y 4B7K-7MPL-Y 4J2R-6HHJ-2 6H7F-06MT-7 184A-44NB-8 2518-4CLX-9 4Y40-2RHR-Z 5Y6J-3HL1-E 241K-18LJ-K 3R04-4ZPR-B 5B5G-0ZNF-T 4N77-1HM0-D 7W49-4XM7-M 723D-20JM-C 2V2W-3VM1-X 4T12-4BPG-8 5V3L-28MC-C 6J2K-47P7-C 2975-27LY-6 2E48-7GN2-3 2K0X-0TLA-F 302F-7YK1-P 3215-4JK4-E 3B05-6RJX-W 530G-60JV-Z 5843-5RM5-X 5J6K-0RGF-P 5U6T-6XMZ-X 684L-2BNM-Y 6K5U-66H9-G 743H-46MR-4 783K-6VGP-M 7F1U-7TJA-7 7U09-3WPK-T 0Z69-7VM6-F 1063-19MD-6 114M-03P1-2 1Y1E-50P2-J 2P5C-6JK9-C 7P27-0CKW-N 0J71-6UGD-Z 1H2D-0NNG-K 1X0A-64MU-D 3D1B-0ALR-A 620Z-2DMM-Y 6A3F-0KN0-B 0B5K-5AGH-7 333Y-7ZPB-9 6U33-3MMP-A 2U6M-2XHV-0 5F72-2NL7-Y 5K53-30PD-P 2J0X-0TLA-J 5034-61K2-8 6W2Z-7NPM-G 136A-1PJ5-1 3J5B-1NH8-3 4867-5XN6-H 6573-5WKF-6 017L-0VKT-B 0A31-5BNT-P 2J36-04K8-W 5D5J-0JLM-A 1A7A-49M4-2 0W02-1FHE-1 140F-4MHC-8 0856-68PX-Z 3R4K-7WMK-F 4G2R-6HHJ-8 7Y0V-08NR-4 027J-7LPC-9 1B0T-7AHH-U 2A1W-48PE-A 3W0K-6GLT-1 4R2H-3YNZ-B 5B72-2NL7-A 0K6R-0PLF-Z 3L13-0MNA-A 6255-58M8-0 065K-5AGH-N 156F-39G4-Z 277T-5KGZ-J 2907-4RG3-F 4E6B-2ZKV-W 5F29-2WG5-2 7L1H-5NMA-T 7N27-0CKW-T 1F4C-40KU-1 1208-4DL4-W 4R0G-60JV-1 5472-2NL7-Z 5R10-2GGN-6 7E1H-5NMA-B 7G6C-3BNE-3 3T5P-0YG8-Y 0V4F-34MB-H 3W4N-43JR-N 4R1C-1EGA-C 4Z5G-0ZNF-Y 5T5A-26K6-0 761Z-1WJ2-J 007B-4EJH-V 2F5M-55J9-U 2T2T-05HF-5 440L-4FL0-9 4V43-5RM5-5 5F6T-6XMZ-Y 711U-7TJA-H 4W2L-2TP9-K 0H63-5EHN-Y 1K01-1FHE-A 0F69-1PJ5-D 3L46-12JD-B 7A09-64MU-F 6419-6NGR-N 165D-5VMH-D 286M-3KLU-7 4W7R-5KGZ-0 5G1Y-1WJ2-5 6V52-30PD-D 726U-52P8-7 781H-1KG1-A 295M-4LGG-B 687V-7BG9-D 1Y1W-2MNL-F 776C-4TL3-N 3913-59N8-2 3H6V-21KC-D 4P5G-10GT-2 1E5N-0YG8-G 4H2B-5YJP-0 5030-5BNT-Z 5Y5U-2PJT-E 6M0P-3TLN-A 1Z0M-0FKE-V 3161-74NU-4 7127-6MKH-8 0X4G-0GN9-U 1D5N-0YG8-K 1W1D-50P2-7 1N5L-55J9-M 3204-6RJX-6 454X-5JHY-E 4R5J-5AGH-B 5V2K-2TP9-4 7U76-1HM0-D 3W35-04K8-C 604P-37N1-E 6939-3JGK-K 3T0L-0FKE-U 637V-7BG9-W 256D-1JPH-X 2M1B-1EGA-6 4H2L-1RHT-2 1K5L-55J9-Y 250N-17M9-D 4Z68-7VM6-U 5T2K-2TP9-A 1F4H-1CJJ-L 380K-4FL0-D 6R70-6UGD-N 6Y1L-1TLH-A 6Z1H-1KG1-6 003W-3UN7-M 0302-5TLL-M 1L48-4XM7-2 452Y-7NPM-6 571Y-1WJ2-0 7E2A-6DHP-0 3846-12JD-F 0G7A-4EJH-U 724E-34MB-4 1T36-4KHG-B 402H-6LPP-V 422Y-7NPM-F 0169-1PJ5-P 2L7D-2UGW-W 1W5M-4LGG-K 2215-5DJ6-4 4843-77KZ-X 5L74-27LY-H 1975-1LMN-R 7G76-1HM0-B 1T6M-3KLU-M 2D3V-3PJ8-1 3951-29H4-6 093T-6YM2-4 0P5D-5VMH-V 6X1X-3CH6-V 2015-5DJ6-A 5Z39-3JGK-J 3P7G-7CNC-6 5210-4GJY-8 5K5E-1YML-9 670P-3TLN-L 3L7E-06MT-G 6T49-44NB-Z 7U02-5TLL-9 0H4B-40KU-B 131T-7TJA-0 0N4C-2YHB-2 0W50-53NK-L 1B2M-79HL-2 1V0N-17M9-C 2479-49M4-2 2T13-59N8-K 3A3P-51MJ-0 3M12-0MNA-N 475G-10GT-J 610R-7AHH-2 650D-63JK-E 6L1L-1TLH-8 7D76-1HM0-L 7Y60-5UGY-J 4845-54M3-Y 5L5X-32PN-Z 2X46-12JD-H 0X5N-0YG8-4 505A-1NH8-6 3P2H-6LPP-P 4Z5A-1NH8-A 6D6U-52P8-7 7D1F-01JC-M 787B-1XPT-M 347K-0VKT-E 4R5V-11KG-Z 0N1E-7HJU-5 1F5C-7UMF-A 387Z-71KX-P 5T39-3JGK-4 715F-0ZNF-4 6P62-19MD-B 635Z-2KH5-4 092D-2FMY-W 0A4G-0GN9-K 1H0C-69LP-U 2J16-1MHK-9 2U4U-45K5-5 4E2E-7YK1-V 6C2N-0WPA-D 6N62-19MD-E 2205-0UH7-P 2M1A-0ALR-2 2T4U-45K5-8 3C5R-3FHA-5 425G-10GT-1 0D0M-4AH2-X 073G-46MR-H 145L-55J9-B 4Y55-68PX-8 5C19-6NGR-Z 6D3Z-2RHR-8 162M-79HL-H 6521-07LZ-0 7N69-1PJ5-H 191D-50P2-0 4P5V-11KG-2 661U-5LH0-D 7F0U-08NR-0 2A24-5CKL-R 5F5X-32PN-E 0U18-2JPY-C 386B-3BNE-E 714V-7RPJ-P 7676-1HM0-9 094B-40KU-3 0V1T-7TJA-T 0V4H-1CJJ-H 6H1X-3CH6-Z 0V75-1LMN-3 3B54-58M8-P 5674-27LY-V 5F1P-6PKN-Y 5K1J-18LJ-J 283A-13JG-H 4630-5BNT-E 4N5A-1NH8-5 5P3N-67ME-9 6V56-0HN3-0 113C-20JM-4 2V51-29H4-H 5U0D-63JK-G 7438-16GM-R 085D-5VMH-8 175C-7UMF-2 1D6D-1JPH-6 2K4U-45K5-U 3C44-7ELE-4 4A6T-5ZH1-1 6W4V-7RPJ-7 273A-13JG-L 2561-74NU-T 6627-6MKH-U 0C1E-7HJU-3 2W3P-51MJ-B 5M2X-65P4-9 2816-1MHK-7 0K25-14LG-Z 460H-6AMX-H 4U2P-6HHJ-T 6D62-19MD-9 2Y2R-05HF-5 4W2V-3VM1-7 5P0P-3TLN-5 6V7B-1XPT-X 754R-5GPU-Y 691X-3CH6-P 024J-7WMK-3 1036-4KHG-N 135C-7UMF-E 4L0Y-2DMM-T 545X-32PN-F 5A4T-57JE-R 623Z-2RHR-9 730U-08NR-4 4X2K-2TP9-Z 692U-1BLC-X 7G6G-7PGV-W 4R2V-3VM1-K 591J-18LJ-G 1K1V-48PE-Z 3Y2E-7YK1-C 6H5F-0ZNF-M 7769-1PJ5-Y 794M-43JR-U 7E4F-1GL2-T 087H-7LPC-6 0N48-4XM7-X 0R1W-2MNL-2 077H-7LPC-9 6L4V-7RPJ-Z 7T4G-0GN9-Z 2M3U-6ZJ1-2 5G6X-3XNY-W 6P76-1HM0-P 1U24-5CKL-9 1W3A-13JG-N 1Z4K-2BNM-D 2213-59N8-R 2M7Z-71KX-H 5L1U-5LH0-4 704D-0EG2-2 0J5L-55J9-2 115M-4LGG-4 2E67-33KR-A 7E17-4CLX-R 455V-11KG-R 0Y2W-7DL9-1 2646-12JD-N 553D-41PZ-B 5A2X-65P4-A 5H21-07LZ-X 687M-2AGC-4 7P4B-40KU-J 2L0L-0FKE-A 573H-5PP3-L 244U-45K5-7 284W-72P0-G 4W7V-7BG9-K 521J-18LJ-5 5F1U-5LH0-K 0P4Y-78J7-V 2M5R-3FHA-B 2X44-7ELE-J 5L2N-0WPA-N 6X64-7XLV-8 084H-1CJJ-A 0M36-4KHG-R 170W-0TLA-3 1879-49M4-P 1E3V-3PJ8-Z 1T4K-2BNM-Z 2D6Z-1ZL8-N 2G7Z-71KX-0 4A66-5XN6-U 4C66-5XN6-L 4F7F-0BLD-V 5D52-30PD-R 5N1L-1TLH-3 5N3Z-2RHR-E 6C4V-7RPJ-P 6N4Z-6KKD-E 7A3T-6YM2-U 1H7N-5FNJ-T 4W2Z-3RLW-L 061T-7TJA-R 756G-7PGV-X 0Z7Y-76MW-6 1015-5DJ6-B 264N-2LKY-K 2P12-0MNA-H 5A5Z-2KH5-G 2Z1G-5NMA-C 332B-5YJP-B 3B7R-5KGZ-L 4V4T-57JE-6 6P3W-3UN7-A 121R-22HW-3 2C0L-0FKE-2 2T2H-6LPP-J 317W-00G0-7 523N-67ME-8 6L0U-08NR-J 767A-4EJH-H 687B-1XPT-N 6T69-1PJ5-9 0F4Y-78J7-K 4U39-3JGK-2 1Y2E-0NNG-X 5G2W-1VNP-A 450L-23HD-U 3Z4R-2LKY-9 161B-6NGR-P 266K-7PGV-J 1J3M-6VGP-Z 6C5J-0ZNF-P 3C4H-34MB-X 1966-5EHN-8 0T7U-56K0-R 176A-7VM6-7 3G2V-05HF-1 6Y79-1HM0-M 7U4C-44NB-E 4V6C-1PJ5-R 351H-01JC-K 453C-3JGK-L 375F-7UMF-K 7A3M-6VGP-H 0V6D-2ZKV-V 7M4J-1GL2-P 7G5U-5HMV-N 0V4G-0EG2-B 3J0H-60JV-5 4348-54M3-0 5G16-59N8-Y 0E5X-2PJT-N 7250-5JHY-Y 6U4M-7WMK-8 3Y4W-57JE-H 713Z-3UN7-Y 2630-65P4-3 5C5L-0JLM-F 1X5Z-2VNH-U 5420-1WJ2-2 4E2D-6DHP-N 190Y-6FKB-V 7858-68PX-U 6E3G-0KN0-G 663N-28MC-C 6G6X-52P8-H 0Z3R-67ME-R 5R3Y-3PJ8-G 325N-73HZ-G 6U22-0XNW-9 2G6W-5ZH1-4 632A-2WG5-N 5531-3RLW-H 1W0U-3TLN-D 6J2L-6LPP-N 2W2B-2WG5-0 0C4Y-7RPJ-G 1P22-0XNW-P 213L-5PP3-W 4U06-4ZPR-6 173D-13JG-8 7741-0LJ3-L 1B1J-01JC-L 0802-71KX-C 067T-5FNJ-E 5K2N-1RHT-X 7C08-4RG3-J 1K7G-2UGW-K 0B5K-10GT-X 2645-5RM5-8 0V5M-73HZ-P 3N03-1FHE-1 4P1N-25G7-U 737K-7LPC-G 7614-0MNA-1 7722-0XNW-1 2V6P-3KLU-G 7N05-5TLL-8 0C0F-69LP-X 2N1Z-3CH6-N 3813-4GJY-B 0214-0MNA-L 0D5N-55J9-K 1966-7XLV-B 3745-77KZ-3 3K2L-47P7-X 151K-5NMA-E 3M7K-7CNC-Z 617X-31N5-0 2N3V-6YM2-X 5A7E-1XPT-4 2F7X-31N5-U 552R-79HL-3 016X-52P8-4 7H5W-2PJT-M 6419-2JPY-T 622Z-7NPM-Y 730B-02P6-L 4Z26-14LG-8 3830-3RLW-T 7X3Y-7ZPB-P 6R5M-55J9-V 720K-6GLT-B 603J-5PP3-T
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information ContactPhilips Customer Services
800-722-9377
Manufacturer Reason
for Recall		During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC iX, a new IP address will be assigned to the MX40. The PIC iX will not recognize the new IP address after reconnecting and therefore the expecting settings sync fails.
FDA Determined
Cause 2		Software design
ActionAn IMPORTANT PRODUCT NOTICE dated 4/19/23 was sent to customers. The actions that you as a customer can take to minimize the effect of the problem This communication should be shared with all clinical staff to review and understand. Place this Important Product Notice with the documentation of the PIC iX Instructions for Use. Additional Actions Dependent on Normal Workflow: 1. Workf/ow A: MX40 Routinely Cleared from Sector: If the MX40 is routinely cleared from the sector upon discharge of a patient then no additional action is required. 2. Workflow B: MX40 not Routinely Cleared from Sector: Option 1: Change Default Settings to Clear Sector Automatically The PIC iX can be setup to routinely clear the sector by executing the following: a. This can be set as the default as needed by selecting the "Clear Sector" selection and the "Clear unlocked Telemetry Devices from bed" in the "Configuration, Patient Management/Workflow", as highlighted in the image below: Option 2: Clear MX40 from Sector Manually The MX40 can be cleared from the sector manually by following the steps below: a. Identify the sector to be cleared from the PIC iX. These steps may be repeated for all sectors in use if they are not routinely cleared. b. Select the "Manage Patient" button and the "Manage Patient" window will display. c. Select the "Clear Sector'' button and the discharge window will display. d. Check the box next to the "Clear Sector'' option, as shown in the example Image 4 below: e. Selecting the "Cancel" button does not change the sector assignment. Finalize the process by selecting the " Discharge" button. 3. Workflow C: Clear Sector Option Not Available: In some configurations, the clear sector function will not be available. If this occurs, please contact the local response center for guidance on how to proceed. 4. The actions planned by Philips to correct the problem A Philips representative will reach out to you to arrange for a software upgrade to your device. This upgrade wi
Quantity in Commerce591 devices
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DSI
-
-