Reported Apr 25, 2018 · Terminated
Achieva 1.5T
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?
Achieva 1.5T
8 of 8 products
| Model / number | Product as published |
|---|---|
781173 | Nova (Dual) |
781178 | Achieva 1.5T Initial Systems |
781196 | Achieva 1.5T Nova |
781283 | Achieva 1.5T Conversion |
781296 | Achieva 1.5T |
781343 | Achieva 1.5T R5 based |
781346 | Achieva 1.5T Conversion R5 based & |
781382 | Achieva 1.5T Product Usage: Indicated 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):
335 of 335 codes
3255022129202262171521558218052213413005200272178921264212361207820129216392002133037212302123120249321712149320149877020154328162017320260220962199920050202131207421968325082148221688390353900521935215722007112100121242189139068216092231520106390602199832080186732104520331222073250032219210998715
- (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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