🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: January 18, 2016 Sedecal S.A. Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 485886/SN11000007, 485062/SN11000009, 488169/SN11000011, 485061/SN11000012, 485059/SN11000013, 485060/SN11000015, 489089/SN11000016, 489616/SN11000033, 490027/SN11000034, 489694/SN11000035, 489695/SN11000036, 489696/SN11000037, 490221/SN11000039, 489088/SN11000040, 493566/SN11000047, 493565/SN11000048, 494867/SN11000051, 494941/SN11000052, 492417/SN11000053, 494456/SN11000055, 494865/SN11000056, 494864/SN11000060, 495286/SN11000061, 494866/SN11000062, 494464/SN11000065, 497570/SN11000066, 488171/SN11000068, 494060/SN11000070, 494061/SN11000071, 494062/SN11000072, 494063/SN11000073, 494064/SN11000074, 494065/SN11000075, 497715/SN11000080, 496446/SN11000082, 496387/SN12000003, 495938/SN12000007, 495939/SN12000008, 493364/SN12000022, 493462/SN12000023, 501028/SN12000026, 500739/SN12000027, 500740/SN12000028, 502424/SN12000034, 503143/SN12000036, 503142/SN12000037, 503141/SN12000038, 503144/SN12000039, 503541/SN12000040, 500466/SN12000045, 502721/SN12000047, 505077/SN12000048, 506626/SN12000051, 507607/SN12000054, 507906/SN12000055, 508342/SN12000057, 500468/SN12000058, 496401/SN12000059, 500467/SN12000060, 508838/SN12000061, 508532/SN12000062, 504450/SN12000064, 509718/SN12000068, 510607/SN12000072, 512160/SN12000077, 513477/SN12000080, 513478/SN12000081, 512892/SN12000082, 513848/SN12000084, 512887/SN12000085, 512888/SN12000086, 512890/SN12000087, 508699/SN12000088, 514462/SN12000089, 514461/SN12000090, 514104/SN12000091, 514103/SN12000092, 509062/SN12000107, 508783/SN12000108, 516891/SN12000110, 516896/SN12000111, 497572/SN12000112, 518135/SN12000118, 518342/SN12000119, 518343/SN12000120, 518344/SN12000121, 518345/SN12000122, 518346/SN12000123, 502025/SN12000124, 502026/SN12000125, 12000166, 519326/SN13000005, 519388/SN13000006, 519511/SN13000010, 519506/SN13000011, 519387/SN13000012, 519763/SN13000013, 519434/SN13000014, 520251/SN13000016, 520253/SN13000017, 519762/SN13000018, 520254/SN13000019, 520255/SN13000020, 520256/SN13000021, 520413/SN13000023, 520414/SN13000025, 520415/SN13000026, 520252/SN13000027, 520422/SN13000028, 520418/SN13000030, 520416/SN13000031, 520417/SN13000033, 522633/SN13000035, 522944/SN13000037, 523279/SN13000042, 523349/SN13000043, 13000046, 13000047, 13000048, 13000049, 13000053, 13000054, 13000055, 13000056, 13000057, 13000058, SN13000059, 13000060, SN13000061, SN13000062, SN13000063, 13000067, SN13000069, 13000070, 13000071, SN13000072, SN13000073, SN13000074, 13000075, 13000076, 13000077, 13000078, 13000079, SN13000080, SN13000082, SN13000083, SN13000084, 13000085, SN13000087, SN13000089, SN13000090, SN13000091, 13000092, 13000093, 13000094, SN13000099, SN13000100, SN13000101, SN13000102, SN13000103, SN13000104, SN13000106, SN13000107, 13000109, SN13000112, SN13000113, 519598/SN13000118, 519599/SN13000119, 519600/SN13000120, SN13000125, 13000127, 13000139, 13000140, 13000141, 13000143, 13000144, 13000145, SN13000146, SN13000147, SN13000148, SN13000149, SN13000153, SN13000154, SN13000157, SN7369686, SN13000159, SN13000160, SN13000163, SN13000164, SN13000165, 13000167, 13000168, 13000169, SN13000170, SN13000174, SN13000176, SN13000177, SN13000179, SN13000180, SN13000181, SN13000182, SN13000183, SN13000185, 13000196, 13000199, 13000200, 13000201, 13000202, 13000203, 13000204, 13000205, SN13000206, 14000004, 14000005, 14000006, 14000008, 14000009, 14000010, 14000011, 14000013, 14000014, 14000015, 14000016, 14000017, 14000019, 14000022, 14000024, 14000026, 14000028, 14000029, 14000031, 14000032, 14000033, 14000034, 14000037, 14000038, 14000041, 14000043, 14000046, 14000047, 14000048, 14000049, 14000050, 14000051, 14000052, SN14000061, 14000069, SN14000072, 14000075, 14000077, 14000078, 14000079, 14000080, 14000081, 14000082, 14000084, 14000086, 14000087, 14000088, 14000089, SN14000096, SN14000097, SN14000098, SN14000099, SN14000100, 14000092, 14000083, 14000085, 14000103, 14000106, 14000083, 14000109, 14000112, 14000116, 14000119, 14000118, 14000120, 14000121, 14000122, 14000124, SN14000128, 14000127, 14000126, SN14000130, 14000134, 14000135, 14000138, 14000139, SN15000002, 14100044, 14100045, 14100053, 14100054, 14100085, 14100086, 14100087, 14100088, 14100090, 14100094, 14100095, 14100097, 14100101, 14100104, 14100105, 14100109, 14100111, 14100117, 14100126, 14100127, 14100128, SN14100046, 15100019, 15100023, SN14100047, SN14100055, SN14100071, SN14100072, SN14100073, SN14100074, SN14100075, 15100028, 15100034, 15100035, 15100036, 15100039, 15100040, 15100041, 15100042, 15100047, 15100048, 15100050, 15100071, 15100084, 15100087, 15100088, 15100089, 15100091, 15100092, 15100093, 15100094, 15100095, 15100097, 15100098, 15100101, 15100103, 15100104, SN15100020, SN15100009, SN15100016, SN15100010, SN15100011, SN15100013 and SN15100018.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Sedecal S.A.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Serial Numbers: 485886/SN11000007, 485062/SN11000009, 488169/SN11000011, 485061/SN11000012, 485059/SN11000013, 485060/SN11000015, 489089/SN11000016, 489616/SN11000033, 490027/SN11000034, 489694/SN11000035, 489695/SN11000036, 489696/SN11000037, 490221/SN11000039, 489088/SN11000040, 493566/SN11000047, 493565/SN11000048, 494867/SN11000051, 494941/SN11000052, 492417/SN11000053, 494456/SN11000055, 494865/SN11000056, 494864/SN11000060, 495286/SN11000061, 494866/SN11000062, 494464/SN11000065, 497570/SN11000066, 488171/SN11000068, 494060/SN11000070, 494061/SN11000071, 494062/SN11000072, 494063/SN11000073, 494064/SN11000074, 494065/SN11000075, 497715/SN11000080, 496446/SN11000082, 496387/SN12000003, 495938/SN12000007, 495939/SN12000008, 493364/SN12000022, 493462/SN12000023, 501028/SN12000026, 500739/SN12000027, 500740/SN12000028, 502424/SN12000034, 503143/SN12000036, 503142/SN12000037, 503141/SN12000038, 503144/SN12000039, 503541/SN12000040, 500466/SN12000045, 502721/SN12000047, 505077/SN12000048, 506626/SN12000051, 507607/SN12000054, 507906/SN12000055, 508342/SN12000057, 500468/SN12000058, 496401/SN12000059, 500467/SN12000060, 508838/SN12000061, 508532/SN12000062, 504450/SN12000064, 509718/SN12000068, 510607/SN12000072, 512160/SN12000077, 513477/SN12000080, 513478/SN12000081, 512892/SN12000082, 513848/SN12000084, 512887/SN12000085, 512888/SN12000086, 512890/SN12000087, 508699/SN12000088, 514462/SN12000089, 514461/SN12000090, 514104/SN12000091, 514103/SN12000092, 509062/SN12000107, 508783/SN12000108, 516891/SN12000110, 516896/SN12000111, 497572/SN12000112, 518135/SN12000118, 518342/SN12000119, 518343/SN12000120, 518344/SN12000121, 518345/SN12000122, 518346/SN12000123, 502025/SN12000124, 502026/SN12000125, 12000166, 519326/SN13000005, 519388/SN13000006, 519511/SN13000010, 519506/SN13000011, 519387/SN13000012, 519763/SN13000013, 519434/SN13000014, 520251/SN13000016, 520253/SN13000017, 519762/SN13000018, 520254/SN13000019, 520255/SN13000020, 520256/SN13000021, 520413/SN13000023, 520414/SN13000025, 520415/SN13000026, 520252/SN13000027, 520422/SN13000028, 520418/SN13000030, 520416/SN13000031, 520417/SN13000033, 522633/SN13000035, 522944/SN13000037, 523279/SN13000042, 523349/SN13000043, 13000046, 13000047, 13000048, 13000049, 13000053, 13000054, 13000055, 13000056, 13000057, 13000058, SN13000059, 13000060, SN13000061, SN13000062, SN13000063, 13000067, SN13000069, 13000070, 13000071, SN13000072, SN13000073, SN13000074, 13000075, 13000076, 13000077, 13000078, 13000079, SN13000080, SN13000082, SN13000083, SN13000084, 13000085, SN13000087, SN13000089, SN13000090, SN13000091, 13000092, 13000093, 13000094, SN13000099, SN13000100, SN13000101, SN13000102, SN13000103, SN13000104, SN13000106, SN13000107, 13000109, SN13000112, SN13000113, 519598/SN13000118, 519599/SN13000119, 519600/SN13000120, SN13000125, 13000127, 13000139, 13000140, 13000141, 13000143, 13000144, 13000145, SN13000146, SN13000147, SN13000148, SN13000149, SN13000153, SN13000154, SN13000157, SN7369686, SN13000159, SN13000160, SN13000163, SN13000164, SN13000165, 13000167, 13000168, 13000169, SN13000170, SN13000174, SN13000176, SN13000177, SN13000179, SN13000180, SN13000181, SN13000182, SN13000183, SN13000185, 13000196, 13000199, 13000200, 13000201, 13000202, 13000203, 13000204, 13000205, SN13000206, 14000004, 14000005, 14000006, 14000008, 14000009, 14000010, 14000011, 14000013, 14000014, 14000015, 14000016, 14000017, 14000019, 14000022, 14000024, 14000026, 14000028, 14000029, 14000031, 14000032, 14000033, 14000034, 14000037, 14000038, 14000041, 14000043, 14000046, 14000047, 14000048, 14000049, 14000050, 14000051, 14000052, SN14000061, 14000069, SN14000072, 14000075, 14000077, 14000078, 14000079, 14000080, 14000081, 14000082, 14000084, 14000086, 14000087, 14000088, 14000089, SN14000096, SN14000097, SN14000098, SN14000099, SN14000100, 14000092, 14000083, 14000085, 14000103, 14000106, 14000083, 14000109, 14000112, 14000116, 14000119, 14000118, 14000120, 14000121, 14000122, 14000124, SN14000128, 14000127, 14000126, SN14000130, 14000134, 14000135, 14000138, 14000139, SN15000002, 14100044, 14100045, 14100053, 14100054, 14100085, 14100086, 14100087, 14100088, 14100090, 14100094, 14100095, 14100097, 14100101, 14100104, 14100105, 14100109, 14100111, 14100117, 14100126, 14100127, 14100128, SN14100046, 15100019, 15100023, SN14100047, SN14100055, SN14100071, SN14100072, SN14100073, SN14100074, SN14100075, 15100028, 15100034, 15100035, 15100036, 15100039, 15100040, 15100041, 15100042, 15100047, 15100048, 15100050, 15100071, 15100084, 15100087, 15100088, 15100089, 15100091, 15100092, 15100093, 15100094, 15100095, 15100097, 15100098, 15100101, 15100103, 15100104, SN15100020, SN15100009, SN15100016, SN15100010, SN15100011, SN15100013 and SN15100018.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1084-2016

Related Recalls

Model Number 40KWFXPLUS.004, Mobile X-ray system

SEDECAL SA

Class I - Dangerous

Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

Jun 10, 2025 Other Medical Devices View Details →