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
Product summary
- 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
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.