Sedecal S.A.

2018

• 18 Jul 2018 Z-0488-2019 Class II Open since 2018 A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties. Distribution: US and Canada Submission number: K133782

2016

• 18 Jan 2016 Z-1084-2016 Class II Terminated This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Reason for Recall: Along with the previously noted encoder and gauges problems and corresponding fixes, we have observed that static electricity can also elicit the unwanted behavior. Distribution: Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN,…
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  Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI.
  Submission number: K111725

2015

• 13 Jul 2015 Z-2390-2015 Class II Terminated Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board producing uncontrolled movements and such uncontrolled movements could cause the system to bump into the user or ppatient. Distribution: Distributed US (nationwide) and in Canada. Submission number: K101517

2014

• 6 Aug 2014 Z-1040-2015 Class II Terminated Reports of unexpected movement. Distribution: US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND,…
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  US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI)
  Submission number: K111725