Z-0732-2024Class II

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

Name: Z-0732-2024 (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Creator: Philips North America
Published: 2023-11-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-11-28 / Open, Classified / root cause: software

FDA source

Philips North America began a recall of (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 on 2023-11-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0732-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-28
Posted: 2024-01-13
Recalling firm: Philips North America LLC
Product: (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 254 US; 37 OUS
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 codes and lots: UDI-DI: 00884838099128 Software: CareEvent Version C.03.X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0732-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0731-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-13
Z-0732-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-13

Product code MHX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)