1) CareEvent, Model No. 866435 recallZ-0732-2024 · Philips North America · initiated Nov 28, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0732-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 28, 2023
- Posted by the FDA
- Jan 13, 2024
- Recalling firm
- Philips North America
- Quantity
- 254 US; 37 OUS
- Product code
- MHX
- FDA submissions
- K161164, K153702
- Distribution
- 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
Product description
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Code information (models, lots, serial numbers)
UDI-DI: 00884838099128 Software: CareEvent Version C.03.X
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CareEventPhilips Medical Systems Hsg · System, network and communication, physiological monitors2 recalls4 deaths7 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93638).
- Z-0731-2024 · Open, Classified(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Model No. 866424
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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