Reported Dec 16, 2020 · Terminated
Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording…
Philips North America LLC
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 North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Philips
- IntelliVue X2 Multi measurement ServerM3002A (865039) -
- Product Usageintended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment
- Lot codes and dates
- Serial NumbersUS:
- DE73607502 DE73607498 OUSSystem Serial Number
DE95038935DE73608191DE73608209DE73601727DE73604240DE73601547DE73601596DE73604182DE83617535DE73608259DE83617500DE83617522DE73601651
- Amount recalled
- 16 total: 2 units US ; 14 OUS
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- SD
Why it was recalled
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
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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