Reported Mar 9, 2016 · Terminated
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
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?
SENSE Body Coil 1.5T with identificationused in the ACS NTIntera 1.5T and Achieva 1.5T MR system
- Lot codes and dates
45221315575x45221321985x45221327619x45980005187x45980005189x459800359051
- Amount recalled
- 5672
Where it was sold
Why it was recalled
Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.
This product could cause temporary or reversible health problems — stop using it.
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