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Open, Classified

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

FDA Recall Z-0732-2024 · Posted 2024-01-13

Recalling FirmPhilips North America
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2023-11-28
Product Quantity254 US; 37 OUS

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.

Firm Action

On November 28, 2023, the firm notified affected consignees through URGENT Medical Device Correction letters. This failure is applicable to Apple iOS devices only. If customers use iOS devices (e.g. iPhone, iPad, etc.) to receive event notifications: 1) Please conduct patient monitoring at the central station or patient bedside. 2) Please do not use iOS event notifications for patient monitoring. A Philips representative will contact you to schedule a visit to install a software patch to your device which will correct the current issue. Patch PIC iX 4.2.2 will be provided for PIC iX 4.X and patch CareEvent C.03.07 will be provided for CareEvent C.03.X. If you need any further information, please contact your local Philips representative, or call 1-800-722- 9377.

Root Cause

Software design

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161164CareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems · 2016-06-24K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems · 2016-06-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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