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U.S. Department of Health and Human Services

Class 2 Device Recall Patient Information Center iX

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 Class 2 Device Recall Patient Information Center iXsee related information
Date Initiated by FirmNovember 28, 2023
Date PostedJanuary 13, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0732-2024
Recall Event ID 93638
510(K)NumberK153702 K161164 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Code Information UDI-DI: 00884838099128 Software: CareEvent Version C.03.X
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information ContactPhilips Customer Services
800-722-9377
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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 Commerce254 US; 37 OUS
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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