FDA Device recall Z-1315-2018
IntelliVue X3 Patient Monitor
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of IntelliVue X3 Patient Monitor by Philips Electronics North America, citing the NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1315-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-17 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | n/a |
Product
IntelliVue X3 Patient Monitor.
Reason
The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.
Identifiers
| code_info | Model 867030 - All devices shipped from June 2017 (Updated 8-14-18) Serial No. DE61102743 DE61103908 DE61102877 DE6…Model 867030 - All devices shipped from June 2017 (Updated 8-14-18) Serial No. DE61102743 DE61103908 DE61102877 DE61105176 DE61102652 DE61102659 DE61104847 DE61101457 DE61101460 DE61100472 DE61101176 DE61100535 DE61100101 DE61100544 DE61101308 DE61101569 DE61101001 DE61101266 DE61100411 DE61101279 DE61101110 DE61100173 DE61101283 DE61100511 DE61100153 DE61101302 DE61101480 DE61100832 DE61100139 DE61100176 DE61100845 DE61100201 DE61100558 DE61100243 DE61100466 DE61100240 DE61100293 DE61100678 DE61100910 DE61100202 DE61101132 DE61100561 DE61100172 DE61101010 DE61101158 DE61101409 DE61101427 DE61101218 DE61100700 DE61100526 DE61101004 DE61100927 DE61101441 DE61100755 DE61100753 DE61101456 DE61101462 DE61101463 DE61101464 DE61101465 DE61101466 DE61101470 DE61101471 DE61101475 DE61101476 DE61101478 DE61101479 DE61101481 DE61101483 DE61101484 DE61101486 DE61101487 DE61101489 DE61101494 DE61101496 DE61101501 DE611015 |
|---|
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-1315-2018%22
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