Z-1387-2024Class II

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

Name: Z-1387-2024 CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version...
Creator: Philips North America
Published: 2024-02-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2024-02-28 / Open, Classified

FDA source

Philips North America began a recall of CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X on 2024-02-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1387-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-28
Posted: 2024-03-27
Recalling firm: Philips North America LLC
Product: CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Product code: MSX System, Network And Communication, Physiological Monitors
Reason for recall: 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: Under Investigation by firm
Action: 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
Quantity in commerce: 2,323 Units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 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 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1387-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1386-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-27
Z-1387-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-27

Product code MSX

K161164Class IICareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems / cleared 2016-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)