CareEvent Event Management System, Model Numbers 866435 and… recallZ-1387-2024 · Philips North America · initiated Feb 28, 2024

Open, Classified

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Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
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Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT Medical Device Correction dated 2/27/24 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users: 1. The Care Assist mobile application should be used in conjunction with other monitoring devices such as a bedside monitor, telemetry monitor and central monitor which continue to provide visual and audible alarm information to inform clinicians of changes in patient status. 2. Customers should update their iOS devices to version 4.1.2 of Care Assist mobile application or greater to eliminate the software defect affecting the annunciation of custom ringtones. 3. Customers should complete the Urgent Medical Device Correction Response Form at the end of the notification to submit both their acknowledgement of this recall and confirm understanding of actions to be taken. 4. This communication should be shared with all clinical staff to review and understand. 5. Place this Urgent Medical Device Correction notification with the documentation of the Care Event and Patient Information Center iX (PlC ix) Revision 4. For Distributors: Philips is requesting customers to return a Response Form to acknowledge receipt and understanding of the Medical Device Correction and confirm that the information from this Letter has been properly distributed to all users that handle the affected product. Together with this letter we are providing a list of affected products that Philips has sold to your organization. As distributor of the affected products, we kindly request that you: Send the attached Medical Device Correction to each customer to whom you have distributed any affected product as soon as possible and no later than? days, together with the Reply Card. Perform a good faith effort to ensure Notification and Reply Form arc deliver to the customer with a minimum of three attempts, and if possible, using multiple contact methods. Actions planned by Philips to correct the problem 1, The action by Philips

Recall details

Recall number: Z-1387-2024
Status: Open, Classified
Initiated by the company: Feb 28, 2024
Posted by the FDA: Mar 27, 2024
Recalling firm: Philips North America
Quantity: 2,323 Units
Product code: MSX
FDA submissions: K161164
Distribution: Worldwide - US Nationwide distribution.

Product description

CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

Code information (models, lots, serial numbers)

Show the full code information (7k characters)

UDI-DI: (01)00884838099128(10)C.03.00; Serial Numbers: 5T6W-21KC-4 3L0R-7AHH-C 1F1G-01JC-6 415A-26K6-9 605K-5AGH-2 5J5G-0ZNF-4 7A6D-4TL3-Y 233Z-0LJ3-C 142W-3VM1-3 1863-19MD-E 3F0T-7AHH-C 4R5K-5AGH-W 2T5M-55J9-W 0U6Z-70HU-B 795Z-7FHX-E 2K3W-3PJ8-0 3T5Z-7FHX-2 0B13-0MNA-8 0R0E-63JK-C 644J-1CJJ-1 470D-63JK-A 2022-0XNW-V 5W2A-5MGJ-D 0141-2RHR-B 6944-5RM5-A 7G7Y-76MW-C 0L09-3WPK-J 2R1E-50P2-3 3967-33KR-R 3H3M-28MC-X 4E1V-5LH0-8 5Y57-68PX-9 150B-02P6-L 3W5D-7UMF-J 0C33-3MMP-U 181U-7TJA-2 2V6Z-1ZL8-C 2468-33KR-T 0J1J-1KG1-4 591H-1KG1-9 194W-72P0-E 2Y57-6TKK-D 2W0U-6WNX-P 7L3W-3PJ8-R 2044-77KZ-8 2G1U-7TJA-9 6E7C-1XPT-M 7L0M-4AH2-1 0U41-6BK3-L 6G5N-4LGG-3 232E-2FMY-X 6R22-07LZ-R 1P5K-5AGH-2 2378-6CPV-2 0550-53NK-T 0F13-59N8-K 1M4Y-78J7-0 0B5Z-7FHX-F 4C04-4ZPR-E 0V6H-7PGV-K 4T3C-1AHM-K 4673-5WKF-5 1F6P-0PLF-T 4F0B-02P6-K 5327-0CKW-L 023M-4WMG-F 490H-6AMX-8 007P-5FNJ-Y 696N-3KLU-H 4Z71-6UGD-L 622C-0NNG-A 4D2U-1VNP-J 5P2P-79HL-W 4B22-07LZ-1 6T6P-0PLF-N 1D7K-0VKT-M 2C5V-11KG-5 6H2D-2FMY-Y 4468-7VM6-B 1F40-2RHR-F 5857-68PX-B 0V4U-45K5-4 5D2H-15LB-L 6F01-38KA-0 6W2M-1RHT-G 0816-5DJ6-5 0U2P-0WPA-U 0D7G-0BLD-N 7B7Y-2CJW-7 0372-6UGD-X 1F0H-23HD-C 3E3T-7KGB-Y 4Z6T-5ZH1-2 176C-3BNE-4 042E-2FMY-W 0X26-14LG-J 4152-30PD-X 6A40-2RHR-T 3C02-71KX-X 657A-49M4-C 0V3W-3PJ8-A 1T6X-1UP5-6 0F4U-57JE-Z 041G-01JC-8 621E-50P2-1 1C67-5XN6-8 686B-7VM6-G 5X4B-40KU-2 3K1U-7TJA-Z 6320-1DNN-P 2H3U-6YM2-V 4Z2W-3VM1-F 1T7E-2UGW-Z 4N03-5TLL-9 2W3V-3PJ8-L 0E08-3WPK-K 3W1U-7TJA-4 7Y6B-2ZKV-9 2B1V-48PE-N 1327-0CKW-R 6A0A-64MU-1 2C7U-4VK7-C 2A5E-5VMH-H 3Z15-4JK4-P 0N24-4YL5-9 4C58-6TKK-J 3R18-5DJ6-L 0607-4DL4-0 5N1E-50P2-6 2V22-07LZ-K 0923-4YL5-Z 1678-09GU-P 4H48-7GN2-R 1A6R-0PLF-T 6K3J-5PP3-0 2D5V-2PJT-M 6K66-4PJB-1 4M2A-5MGJ-3 7A7A-49M4-W 2405-6RJX-J 4V31-5BNT-0 021E-42GL-M 2A00-2CJW-G 110X-3GJ0-Y 3U73-5WKF-A 7Y4K-7WMK-T 7C53-30PD-A 0X61-5UGY-D 2K0X-0TLA-F 3X3X-7ZPB-A 075K-0JLM-J 0P7L-7MPL-F 0R7M-0VKT-P 0U04-4ZPR-8 155C-6JK9-3 1F67-4PJB-3 2D5Z-7FHX-7 2P17-4JK4-J 393L-6VGP-7 3A3B-13JG-V 3K2F-2FMY-X 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4U1J-1KG1-8 522N-79HL-A 5955-68PX-6 595X-32PN-0 5B7G-2UGW-7 5F2J-6LPP-Y 5L33-61K2-V 5M7N-2AGC-F 5N36-3ALK-Y 5P4U-5GPU-C 614P-37N1-B 624D-40KU-L 6330-3RLW-5 6H72-6UGD-D 717L-7MPL-A 774G-1GL2-Z 7A29-0CKW-Z 7B0H-23HD-J 7T2Z-65P4-X 7U0D-69LP-A 7W2F-7YK1-Z 7W46-54M3-G 150E-63JK-4 3X1H-5NMA-2 5F43-6BK3-J 3F73-5WKF-B 641X-2MNL-9 047L-0VKT-2 073E-0KN0-9 074Y-5JHY-X 321K-5NMA-M 3A6H-7PGV-3 5958-0HN3-T 6H2Y-65P4-5 086V-52P8-D 0V29-6MKH-3 1R2N-79HL-C 1U2B-5YJP-8 4T0A-64MU-N 5R0V-08NR-R 7T4A-2HJF-L 101T-7TJA-9 7E5T-66H9-D 2C47-7GN2-R 2K6H-3HL1-1 2M71-6UGD-L 4818-4CLX-Y 5U7F-0BLD-T 5Y1M-1TLH-W 6K48-7GN2-G 6P35-3ALK-9 7F0V-6FKB-G 064Y-78J7-E 0M74-3ZKP-C 0U4A-4XM7-K 0Y6E-39G4-4 1B6E-39G4-W 1F2W-7DL9-D 1M47-7GN2-Y 1M5L-55J9-R 1M74-3ZKP-B 1N5H-0ZNF-D 2710-2GGN-W 2C0G-60JV-7 2F5N-4LGG-A 2T15-59N8-M 2U4V-45K5-N 313P-51MJ-V 354G-34MB-1 3B6K-3NNV-D 3N45-77KZ-N 3N4G-1GL2-N 460E-4MHC-E 4615-4JK4-1 4J0Z-2GGN-H 4R16-5DJ6-H 4W2L-47P7-1 512V-3VM1-P 5D5A-1NH8-Z 5W0A-64MU-C 5Z7M-7JG6-7 611V-22HW-L 6511-2GGN-F 651G-7HJU-L 676F-39G4-L 6A5H-10GT-R 6E0E-63JK-4 6W4D-0EG2-F 6Z31-24GX-0 785K-73HZ-7 7B4G-0GN9-9 7N7K-7LPC-P 5B1T-6PKN-C 1P3M-4WMG-F 125Z-7FHX-9 143A-13JG-Y 0E0E-63JK-A 0F10-2GGN-6 0N7K-7CNC-Z 0R1M-4HGE-X 0T4J-0GN9-8 0U14-59N8-3 0W64-5EHN-E 0Y2J-47P7-X 153X-3UN7-N 180D-69LP-6 1964-5EHN-6 2R3K-6VGP-A 392A-5MGJ-8 3L1J-1KG1-V 4426-14LG-T 4T1X-3CH6-9 5259-6TKK-0 5C7L-0VKT-5 5M4Z-6KKD-J 5Z4R-2LKY-7 6A6D-4TL3-Z 6T18-4CLX-9 6V5D-7UMF-J 735A-26K6-0 7N7D-62PF-7 7V0B-3WPK-R 7W5X-2VNH-M 2U0H-23HD-A 136H-7PGV-U 6F1L-1TLH-P 574R-37N1-B 1X0H-23HD-2 604G-1GL2-M 7F2Y-65P4-A 1H3G-41PZ-Y

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

CareEvent
Philips Medical Systems Hsg · System, network and communication, physiological monitors
2 recalls4 deaths7 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 94185).

Z-1386-2024 · Open, Classified
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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