Reported Aug 10, 2016 · Terminated
IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever…
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
- Patient Monitor Product UsageThe 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
- Lot codes and dates
- Serial Numbers listed for US/VA/DOD Consignees. For OUS serial numbers, plesae refer to customer list.
2,708 of 2,708 codes
DE35122625DE35142133DE35142134DE35115647DE35106078DE35129184DE35129185DE35147659DE35147653DE35119998DE35119999DE35120000DE35120001DE35120021DE35120022DE35120023DE35120024DE35120025DE35120026DE35120027DE35120028DE35120029DE35120030DE35120031DE35120032DE35120034DE35120035DE35120036DE35120037DE35120038DE35120039DE35120040DE35120041DE35120042DE35120043DE35120044DE35120045DE35120046DE35120047DE35120048DE35120052DE35120053DE35120055DE35120056DE35120057DE35120058DE35120059DE35120060DE35120061DE35120062DE35120063DE35120064DE35120065DE35120067DE35120068DE35120069DE35120071DE35120072DE35120079DE35120080
- Serial Numbers listed for US/VA/DOD Consignees. For OUS serial numbers, plesae refer to customer list.
- Amount recalled
- 50,495
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
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an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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