Home / Recalls / Philips North America / Z-0732-2024

Z-0732-2024 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
January 24, 2024
Initiation Date
November 28, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
254 US; 37 OUS

Product Description

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

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.

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

Code Information

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

Other recalls by Philips North America

  • Z-1315-2026 Class II — Brilliance iCT; Product Code (REF): 728306; (January 7, 2026)
  • Z-1318-2026 Class II — Spectral CT 7500 on Rails; Product Code (REF): 728334; (January 7, 2026)
  • Z-1317-2026 Class II — Spectral CT; Product Code (REF): 728333; (January 7, 2026)
  • Z-1316-2026 Class II — IQon Spectral CT; Product Code (REF): 728332; (January 7, 2026)
  • Z-1156-2026 Class II — Patient Information Center iX; Software Version Number: 4.5.0 (December 22, 2025)
  • Z-1033-2026 Class II — Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. (December 12, 2025)
  • Z-1210-2026 Class II — Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. M (December 3, 2025)
  • Z-1215-2026 Class II — SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with S (December 3, 2025)
  • Z-1208-2026 Class II — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11. (December 3, 2025)
  • Z-1207-2026 Class II — Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW (December 3, 2025)