Reported Apr 25, 2018 · Terminated
ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images,…
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?
- ACS-NT
- Model 78108 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):
195 of 195 codes
509754265519550752555059537952575316514450025300544054825014549250195423525652935382531954205030547754885193508553475287519554815370547453605352510651355495531354135245514253785411521451515053522252015381524653065429544153245273504851245211
- (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.
Want the full recall guide?
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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