Reported Sep 24, 2014 · Terminated
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images…
Philips Medical Systems (Cleveland) Inc.
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 Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
- Lot codes and dates
265 of 265 codes
System Code #728243728244Serial #: 702271187151729873437360736173627363736473657366736773687369737073717372737373747375737673777378737973807381738273837384738573867387738873897390739173927393739473957396739773987399740074017402740374047405740674077408740974107411
- Amount recalled
- 257
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
Why it was recalled
Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode.
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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