Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
FDA device recall Z-1827-2024 · posted 2024-05-15 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- Event Catalog information does not save when copied and transferred from one unit to another.
- Action taken
- Consignees were sent an "URGENT Medical Device Correction," notification, dated 4/12/24. Consignees are instructed in the notification to review in Events Monitor and confirm the expected category is assigned for the reviewed event. If events are not assigned to the correct category consignees are not to depend on event notification for patient monitoring. The provided recall notification should be provided to all users of affected devices and to those the device was further distributed, for their awareness. Philips will contact consignees to schedule a visit from a Philips Field Service Engineer to provide a software patch (PIC iX 4.2.4) to correct the issue. Consignees with any questions are to contact their local Philips representative or call 1-800-722-9377.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 358 units (US: 45; OUS: 313)
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, MA, MI, MN, MO, NJ, NM, NY, OH, PA, TN, TX, WA, WV, & DC. The countries of AE, AT, AU, BE, BR, CA, CH, CZ, DE, DK, ES, FI, FR, G
- Date initiated
- 2024-04-19
- Date posted
- 2024-05-15
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| M3290B Philips IntelliVue Information Center iX (K153702) | Philips Medical Systems | 2016-06-13 |