Reported May 1, 2019 · Terminated
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574…
Carestream Health, 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: Carestream Health, Inc. · 1049 W Ridge Rd · Rochester, NY · 14615-2731
Is this the product you have?
- OnSight 3D Extremity System- X-Ray, Tomography
- Computed System Catalog Numbers1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over
- Lot codes and dates
- US Serial Numbers
5800858558007506580000205800849358000015580075025800750458008494580075035800801858007505580085005800801158008014
- OUS
1001220005200122001620007200171001810004100072000420008100231000920019200131000210003100141001020006200222000320010
- US Serial Numbers
- Amount recalled
- 37 units
Where it was sold
Why it was recalled
When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
This product could cause temporary or reversible health problems — stop using it.
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