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Recall Observatory FDA recall evidence

Device product

(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

November 28, 2023

Class II

Product summary

Firm
Philips North America
Event
Event 93638
Status
Ongoing
Classification
Class II
Quantity
41 US; 773 OUS
Official record key
device-enforcement:Z-0731-2024

Official wording

Reason: 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

Derived failure modes

  • 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.