Reported Apr 3, 2024 · Ongoing

Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware)…

Philips North America

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America · 222 Jacobs St · Cambridge, MA · 02141-2296

Is this the product you have?

Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X

Lot codes and dates: UDI-DI(01)00884838104594(10)4.0.1 (01)00884838104594(10)4.0.2 (01)00884838112070(10)4.1.0 (01)00884838112070(10)4.1.1 (01)00884838121782(10)4.2.0 (01)00884838121782(10)4.2.1
Serial Numbers
208 of 208 codes
7G6G-7PGV-W
5971-2NL7-Z
6D62-19MD-9
463N-67ME-X
5K2A-6DHP-K
5E42-35J4-P
4E6Z-70HU-B
1T12-0MNA-C
2H34-3MMP-U
6P1E-7HJU-W
3R6X-3XNY-6
7F50-53NK-L
3Z3B-1AHM-H
0C5Y-7FHX-V
0X7R-2AGC-Y
0P5D-5VMH-V
6627-6MKH-U
5J7B-1XPT-T
7U4C-44NB-E
2Y7R-5KGZ-W
1P22-0XNW-P
1004-6RJX-E
1U0P-0FKE-C
396T-5ZH1-5
610R-7AHH-2
0B5K-10GT-X
0Z7K-0VKT-0
2A5D-1NH8-Y
2Y5M-5AGH-E
3153-2END-M
4H2B-5YJP-0
5F6T-6XMZ-Y
5Y3Z-2RHR-N
6B6G-3DKJ-4
7Z05-0UH7-V
5H6A-2ZKV-1
1J61-2KH5-M
612A-2WG5-W
737K-7LPC-G
7Z3Y-0LJ3-2
3T0R-7AHH-X
7A4Y-78J7-V
2P5H-0JLM-Y
002A-5MGJ-6
0X63-19MD-G
221G-5NMA-3
4W6U-0PLF-2
7A3M-6VGP-H
7J0C-69LP-H
0V4G-0EG2-B
2K1C-42GL-Y
4M77-1HM0-G
4R5J-5AGH-B
4T62-19MD-7
4W08-0UH7-U
5Y2X-65P4-E
6H5T-3FHA-4
6K59-0HN3-B
2X7R-5KGZ-Z
016X-52P8-4
Amount recalled: 257,183 Units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade)…

Where it was sold

Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from Philips North America

Philips Patient Information Center iX Sep 23, 2026
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2.… May 6, 2026
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW… Feb 4, 2026
Patient Information Center iX Jan 28, 2026
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL… Dec 17, 2025
Cardiac Workstation 5000 Oct 22, 2025

23 in total.

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