Reported Nov 19, 2014 · Ongoing
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed…
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?
- MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.
- Lot codes and dates
- Model Number728131
- Serial Number(s)
629 of 629 codes
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
- P16EVO140008 Model Number728132
- Serial Number(s)
78 of 78 codes
EP16ER100003EP16ER100004EP16ER100005EP16ER100007EP16ER100008EP16ER110003EP16ER110004EP16ER110005EP16ER110006EP16ER110007EP16ER110008EP16ER110009EP16ER110010EP16ER110011EP16ER110012EP16ER110013EP16ER110014EP16ER110015EP16ER110016EP16ER110017EP16ER110018EP16ER110019EP16ER110020EP16ER110021EP16ER110022EP16ER110023EP16ER110024EP16ER120001EP16ER120002EP16ER120003EP16ER120004EP16ER120005EP16ER120006EP16ER120007EP16ER120008EP16ER120009EP16ER120010EP16ER120011EP16ER120012EP16ER120013EP16ER120015EP16ER120016EP16ER120017EP16ER120018EP16ER130001EP16ER130002EP16ER130003EP16ER130004EP16ER130005EP16ER130006EP16ER130007EP16ER130008EP16ER130009EP16ER130010EP16ER130011EP16ER130012EP16ER130013EP16ER130014EP16ER130015EP16ER130016
- Amount recalled
- 708
Where it was sold
Why it was recalled
"The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. "L" and "R" of scan images are reversed and this is not consistent with the patient actual position. "When a surview which is longe
This product could cause temporary or reversible health problems — stop using it.
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