Reported Mar 16, 2016 · Terminated
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist…
Sedecal S.A.
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: Sedecal S.A. · Pol. Industrial Rio De Janiero · Algete, N/A · N/A
Is this the product you have?
- Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
- Lot codes and dates
- Serial Numbers
352 of 352 codes
485886/SN11000007485062/SN11000009488169/SN11000011485061/SN11000012485059/SN11000013485060/SN11000015489089/SN11000016489616/SN11000033490027/SN11000034489694/SN11000035489695/SN11000036489696/SN11000037490221/SN11000039489088/SN11000040493566/SN11000047493565/SN11000048494867/SN11000051494941/SN11000052492417/SN11000053494456/SN11000055494865/SN11000056494864/SN11000060495286/SN11000061494866/SN11000062494464/SN11000065497570/SN11000066488171/SN11000068494060/SN11000070494061/SN11000071494062/SN11000072494063/SN11000073494064/SN11000074494065/SN11000075497715/SN11000080496446/SN11000082496387/SN12000003495938/SN12000007495939/SN12000008493364/SN12000022493462/SN12000023501028/SN12000026500739/SN12000027500740/SN12000028502424/SN12000034503143/SN12000036503142/SN12000037503141/SN12000038503144/SN12000039503541/SN12000040500466/SN12000045502721/SN12000047505077/SN12000048506626/SN12000051507607/SN12000054507906/SN12000055508342/SN12000057500468/SN12000058496401/SN12000059500467/SN12000060508838/SN12000061
- Serial Numbers
- Amount recalled
- 349 systems
Where it was sold
Why it was recalled
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.
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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