510(k) K102495 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Sep 30, 2010 |
| Received | Aug 31, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2018 | Philips Electronics North America Corporation Intellivue iX Information Center Software - All PIIC iX Surveillance stations including:
866023 IntelliVue Info Center iX A.0
866117 PIIC Classic Upgrade
866389 IntelliVue Info Center iX B.0, C.0
8671 Terminated |
MHX | None listed |
| Feb 23, 2016 | Philips Electronics North America Corporation Philips Healthcare IntelliVue Info Center iX, A.0 866023 Terminated |
MHX | None listed |
| Feb 23, 2016 | Philips Electronics North America Corporation Philips Healthcare PIIC Classic Upgrade, 866117
Physiological, Patient Monitor (With Arrhythmia Detection or Alarm) Terminated |
MHX | None listed |
| Feb 23, 2016 | Philips Electronics North America Corporation Philips Healthcare IntelliVue Info Center iX, B.0, 866389
Physiological, Patient Monitor (With Arrhythmia Detection or Alarm) Terminated |
MHX | None listed |
| Dec 4, 2015 | Philips Medical Systems, Inc. Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue:
866023 IntelliVue Info Center iX
866024 PIIC iX Upgrade
866117 PIIC Classic Upgrade
The intended us Terminated |
MHX | None listed |
| Jun 11, 2014 | Philips Healthcare Inc. Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor. Terminated |
MHX | None listed |
| Dec 10, 2012 | Philips Healthcare Inc. Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX
The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.