CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. recalled
Philips North America is recalling (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no., distributed nationwide in the US. The recall was initiated on 28 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0732-2024
- FDA event ID
- 93638
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Nov 2023
- FDA classified
- 13 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 28 Nov 2023 | Recall initiated by company | |
| 13 Jan 2024 | Classified by FDA | +46 days |
| 24 Jan 2024 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Where it was distributed
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
Nationwide CaliforniaGeorgiaIowaMassachusettsMichiganMinnesotaNew JerseyNew MexicoNew YorkOhioPennsylvaniaTennesseeTexasWashingtonWest Virginia
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI: 00884838099128 Software: CareEvent Version C.03.X
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93638This product is part of a recall event; the main page for the event is Patient Information Center iX recalled by Philips North America.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Patient Information Center iX recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
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