Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) runni
Summary
The FDA issued a Class II for Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Exp by Philips North America. Reason: 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 w.
Details
Source
Device Recall
External ID
Z-1386-2024
Action Date
2024-04-03
Status
Ongoing
Category
device
Product Description
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/Code Info: 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: 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 041V-48PE-D 0A61-74NU-C 0J71-6UGD-Z 0P4Y-78J7-V 0R1W-2MNL-2 0T41-35J4-A 0V7B-4EJH-A 0W65-4PJB-V 1036-4KHG-N 156Y-70HU-R 1A4K-2BNM-C 1D5N-0YG8-K 1Y2E-0NNG-X 1Z7W-00G0-F 2141-35J4-G 2630-65P4-3 2A5H-1YML-U 2K53-2END-0 2M2G-15LB-E 2N78-6CPV-9 2V3T-67ME-K 2X44-7ELE-J 2X46-12JD-H 2Z73-2NL7-2 302H-6LPP-W 3107-4RG3-6 375F-7UMF-K 3B54-58M8-P 3K33-61K2-0 3Z4R-2LKY-9 483K-28MC-M 4J6V-6XMZ-R 4N5A-1NH8-5 4T7D-4EJH-E 4V52-30PD-F 4V6C-1PJ5-R 521J-18LJ-5 591J-18LJ-G 5A4L-1CJJ-J 5A4T-57JE-R 5C4L-7WMK-2 5F72-2NL7-Y 5G1Y-1WJ2-5 5Y6J-3HL1-E 6031-24GX-X 684V-57JE-Z 693T-6YM2-Y 6D2X-1BLC-4 6F3G-46MR-K 6L0D-02P6-4 6M5J-0JLM-H 6N1K-25G7-8 6U32-24GX-0 6Y79-1HM0-M 6Z1H-1KG1-6 6Z5N-0YG8-R 724E-34MB-4 7U76-1HM0-D 7Y5Z-7FHX-F 4L7J-7MPL-J 0D6E-39G4-P 5B0U-08NR-E 6F2V-1BLC-W 003W-3UN7-M 2V57-6TKK-N 3D5U-2PJT-3 3T5P-0YG8-Y 0N1E-7HJU-5 1J5H-1YML-3 1W6W-21KC-Z 284W-72P0-G 325N-73HZ-G 4U39-3JGK-2 5G2W-1VNP-A 5L5X-32PN-Z 617X-31N5-0 017L-0VKT-B 067L-7MPL-2 116V-21KC-Z 116Z-1ZL8-V 1305-0UH7-M 1K1B-1EGA-D 2P1T-75JN-B 3055-68PX-3 350Y-2DMM-7 3A0H-6AMX-6 3V31-7NPM-F 414L-03P1-E 4R03-1FHE-U 4R1J-18LJ-4 523N-67ME-8 5X3N-67ME-P 623Z-2RHR-9 6633-24GX-D 670F-60JV-1 6L0F-60JV-U 713Z-3UN7-Y 7676-1HM0-9 7C5C-7UMF-D 1135-04K8-Z 094B-40KU-3 2C6N-3KLU-C 2V2W-3VM1-X 545X-32PN-F 706P-0PLF-0 6X1X-3CH6-V 264N-2LKY-K 3C44-7ELE-4 3K0J-6GLT-B 6T49-44NB-Z 2V51-29H4-H 4K30-5BNT-7 5N40-2RHR-N 0Y0L-0FKE-E 3F5L-5AGH-9 6U2G-3YNZ-J 032M-79HL-V 115M-4LGG-4 2L0L-0FKE-A 0D1V-48PE-J 4L7Y-00G0-F 567W-7BG9-5 6E64-7XLV-M 6J3E-0KN0-2 534U-57JE-Y 472X-65P4-L 7T0A-02P6-1 0U28-2WG5-M 0F6V-6XMZ-5 0T1M-18LJ-R 0Y5Z-7FHX-N 1256-68PX-G 1R44-7ELE-2 2W26-0CKW-V 3Z3G-0KN0-0 4H5T-0YG8-P 4R0G-60JV-1 5K0P-17M9-H 6L3G-46MR-4 3F3D-41PZ-F 661M-4HGE-D 5G2A-6DHP-W 6M6N-0DN4-G 121R-22HW-3 7W3Y-0LJ3-B 4W2V-3VM1-7 6R2J-47P7-9 0K6E-39G4-5
Quantity Affected: 257,183 Units
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.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-28
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America has 126 FDA actions in our database, including 126 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America have FDA actions?
Philips North America has 126 FDA actions in our database, including 126 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1386-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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