Reported Apr 18, 2018 · Terminated
IntelliVue X3 Patient Monitor.
Philips Electronics North America Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- IntelliVue X3 Patient Monitor.
- Lot codes and dates
- Model 867030 - All devices shipped from June 2017 (Updated 8-14-18) Serial No.
975 of 975 codes
DE61102743DE61103908DE61102877DE61105176DE61102652DE61102659DE61104847DE61101457DE61101460DE61100472DE61101176DE61100535DE61100101DE61100544DE61101308DE61101569DE61101001DE61101266DE61100411DE61101279DE61101110DE61100173DE61101283DE61100511DE61100153DE61101302DE61101480DE61100832DE61100139DE61100176DE61100845DE61100201DE61100558DE61100243DE61100466DE61100240DE61100293DE61100678DE61100910DE61100202DE61101132DE61100561DE61100172DE61101010DE61101158DE61101409DE61101427DE61101218DE61100700DE61100526DE61101004DE61100927DE61101441DE61100755DE61100753DE61101456DE61101462DE61101463DE61101464DE61101465
- Model 867030 - All devices shipped from June 2017 (Updated 8-14-18) Serial No.
- Amount recalled
- 975 (updated 8-14-18)
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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