Reported Apr 25, 2018 · Terminated
Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device. It…
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?
Intera 1.0T1) Stellar Model 7811022)
- Pular Model 781103 Product UsageIndicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities
- Lot codes and dates
- (Added 6/25/18):
71497210708272127015717470811032770731033270637040711970957272101047005721370571032671281033972301032971837098100537080701171787139712610192721770667171713670387050
- (Added 6/25/18):
- Amount recalled
- 8,205 units in total
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Potential risk for helium gas inside the MR examination room during a magnet quench
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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