(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Summary
The FDA issued a Class II for (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436 by Philips North America. Reason: 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.
Details
Source
Device Recall
External ID
Z-0732-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Lot/Code Info: UDI-DI: 00884838099128 Software: CareEvent Version C.03.X
Quantity Affected: 254 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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-28
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America has 126 FDA actions in our database, including 126 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America have FDA actions?
Philips North America has 126 FDA actions in our database, including 126 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0732-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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