IntelliVue Patient Monitor Product Usage: The monitors are indicated… — Class II medical device recall Z-2328-2016
Terminated recall by Philips Electronics North America Corporation, reported 2016-08-10, distributed nationwide. If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms wi
| Recall number | Z-2328-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2016-07-26 |
| Classified | 2016-08-03 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2020-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 50,495 |
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 for recall
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an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2328-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.