CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report
Patient Information Center iX (PIC iX) recalled by Philips North America
Philips North America is recalling Patient Information Center iX (PIC iX), distributed nationwide in the US. The recall was initiated on 28 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1386-2024
- FDA event ID
- 94185
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Feb 2024
- FDA classified
- 27 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 28 Feb 2024 | Recall initiated by company | |
| 27 Mar 2024 | Classified by FDA | +28 days |
| 3 Apr 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94185This product is part of a recall event; the main page for the event is CareEvent Event Management System recalled by Philips North America.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CareEvent Event Management System recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
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| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel recalled | Philips North America | Device Malfunction | MA |
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