FDA Device recall Z-2328-2016
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for moni…
- FDA Device
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for moni… by Philips Electronics North America, citing if an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2328-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-26 |
| Published | 2016-08-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
Product
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.
Reason
If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.
Identifiers
| code_info | Serial Numbers listed for US/VA/DOD Consignees. For OUS serial numbers, plesae refer to customer list. DE35122625 D…Serial Numbers listed for US/VA/DOD Consignees. For OUS serial numbers, plesae refer to customer list. DE35122625 DE35142133 DE35142134 DE35115647 DE35106078 DE35129184 DE35129185 DE35147659 DE35147653 DE35119998 DE35119999 DE35120000 DE35120001 DE35120021 DE35120022 DE35120023 DE35120024 DE35120025 DE35120026 DE35120027 DE35120028 DE35120029 DE35120030 DE35120031 DE35120032 DE35120034 DE35120035 DE35120036 DE35120037 DE35120038 DE35120039 DE35120040 DE35120041 DE35120042 DE35120043 DE35120044 DE35120045 DE35120046 DE35120047 DE35120048 DE35120052 DE35120053 DE35120055 DE35120056 DE35120057 DE35120058 DE35120059 DE35120060 DE35120061 DE35120062 DE35120063 DE35120064 DE35120065 DE35120067 DE35120068 DE35120069 DE35120071 DE35120072 DE35120079 DE35120080 DE35120081 DE35120082 DE35120083 DE35120084 DE35120085 DE35120086 DE35120091 DE35127131 DE35127132 DE35127133 DE35127135 DE35120322 DE35120323 DE35120324 DE3512 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2328-2016%22
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