Exact FDA event identifier

Event 93638

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: November 28, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Philips North America

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424

Z-0731-2024

Recall number: Z-0731-2024
Initiated: November 28, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 41 US; 773 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

Code information

UDI-DI: (1) 00884838104594 (2) 00884838112070 (3) 00884838121782 Software: PIC iX Version 4.X

Distribution pattern

Worldwide distribution: US (Nationwide) to states of: CA, GA, IA, MA, MI, MN, NJ, NM, NY, OH, PA, TN, TX, WA, WV; and OUS (Foreign) distribution to countries of: Australia, Austria, Belarus, Belgium, Brazil, Canada, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, India, Indonesia, Ireland, Italy, Japan, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Utd.Arab.Emir., and Uzbekistan

device · product 2 of 2

(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436

Z-0732-2024

Recall number: Z-0732-2024
Initiated: November 28, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America
Quantity: 254 US; 37 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

Code information

UDI-DI: 00884838099128 Software: CareEvent Version C.03.X